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Raltegravir (MK-0518)

Alias: MK-0518; MK0518; MK 0518; MK-0518; Raltegravir; trade name: Isentress
Cat No.:V1830 Purity: ≥98%
Raltegravir (formerly also known as MK-0518; trade name: Isentress) is a novel, potent integrase (IN) inhibitor for WT and S217Q PFV IN with IC50 of 90 nM and 40 nM in cell-free assays, respectively.
Raltegravir (MK-0518)
Raltegravir (MK-0518) Chemical Structure CAS No.: 518048-05-0
Product category: Reverse Transcriptase
This product is for research use only, not for human use. We do not sell to patients.
Size Price Stock Qty
25mg
50mg
100mg
250mg
500mg
1g
Other Sizes

Other Forms of Raltegravir (MK-0518):

  • Raltegravir potassium (MK-0518)
  • Raltegravir sodium
  • Raltegravir-d4
Official Supplier of:
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Purity & Quality Control Documentation

Purity: ≥98%

Product Description

Raltegravir (formerly also known as MK-0518; trade name: Isentress) is a novel, potent integrase (IN) inhibitor for WT and S217Q PFV IN with IC50 of 90 nM and 40 nM in cell-free assays, respectively. Raltegravir is an antiretroviral drug used to treat HIV infection. Raltegravir binds to and inhibits integrase, an HIV enzyme that inserts viral genetic material into the genetic material of the infected human cell. Inhibition of integrase prevents insertion of HIV DNA into the human DNA genome, thus blocking HIV replication. It is the first integrase inhibitors that received FDA approval for HIV treatment.

Biological Activity I Assay Protocols (From Reference)
ln Vitro
PFV IN with the S217H alteration has an IC50 of 900 nM, making it ten times less sensitive to raltegravir. PFV IN exhibited 10% of WT's activity and was inhibited by Raltegravir at an IC50 of 200 nM, suggesting that PFV IN is less sensitive to IN strand transfer inhibitors (INSTIs) than WT IN is. Similar to the WT enzyme, S217Q PFV IN is also susceptible to raltegravir [1]. Glucuronidation, not the liver, is the mechanism of raltegravir metabolism. With a 95% inhibitory concentration of 31±20 nM in human T cell cultures, raltegravir demonstrates strong anti-HIV-1 action in vitro. Raltegravir exhibited anti-HIV-2 activity in CEMx174 cells as well, with an IC95 of 6 nM. Glucuronidation is the main mechanism of raltegravir metabolism. Strong glucuronidase UGT1A1 inducers should not be utilized since they drastically lower raltegravir concentrations. Hepatic cytochrome P450 activity is only slightly inhibited by raltegravir. Neither CYP3A4-dependent testosterone 6-beta-hydroxylase activity nor CYP3A4 RNA expression are induced by raltegravir [2]. Magnesium and calcium have been shown to decrease raltegravir's cellular permeability [3]. Effectively preventing viral replication is possible with raltegravir and related HIV-1 integrase (IN) strand transfer inhibitors (INSTIs) [4]. Latisavue successfully suppressed SIVmac251 replication in the acutely infected human lymphoid CD4+ T cell lines MT-4 and CEMx174, suggesting an EC90 in the low nanomolar range [5].
ln Vivo
Rateltelevir improves the viro-immunological status of nonhuman primates infected with SIVmac251 as it progresses. Raltegravir monotherapy results in an undetectable viral load in one non-human primate[5].
Animal Protocol


ADME/Pharmacokinetics
Absorption, Distribution and Excretion
Absorbed from the gastrointestinal tract.
Feces and urine
Approximately 83% bound to human plasma protein and is minimally distributed into red blood cells (blood-to-plasma partitioning ratio of 0.6).
The major mechanism of clearance of raltegravir in humans is glucuronidation mediated by UGT1A1, the renal clearance of unchanged drug is a minor pathway of elimination of raltegravir (9% of total dose).
Raltegravir (film-coated tablet) is absorbed with a Tmax of approximately 3 hours postdose in the fasted state. Raltegravir AUC and Cmax increase dose proportionally over the dose range 100 mg to 1600 mg. Raltegravir C12hr increases dose proportionally over the dose range of 100 to 800 mg and increases slightly less than dose proportionally over the dose range 100 mg to 1600 mg.
With twice-daily dosing, pharmacokinetic steady state is achieved within approximately the first 2 days of dosing. There is little to no accumulation in AUC and Cmax. The average accumulation ratio for C12hr ranged from approximately 1.2 to 1.6.
The absolute bioavailability of raltegravir has not been established. Based on a formulation comparison study in healthy adult volunteers, the chewable tablet has higher oral bioavailability compared to the 400 mg film-coated tablet.
In subjects who received 400 mg twice daily alone, raltegravir drug exposures were characterized by a geometric mean AUC0-12hr of 14.3 uM.hr and C12hr of 142 nM.
For more Absorption, Distribution and Excretion (Complete) data for Raltegravir (13 total), please visit the HSDB record page.
Metabolism / Metabolites
Hepatic (UGT1A1)
In feces, only raltegravir was present, most of which is likely derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species. Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23% of the dose, respectively. The major circulating entity was raltegravir and represented approximately 70% of the total radioactivity; the remaining radioactivity in plasma was accounted for by raltegravir-glucuronide.
Studies using isoform-selective chemical inhibitors and cDNA-expressed UDP-glucuronosyltransferases (UGT) show that UGT1A1 is the main enzyme responsible for the formation of raltegravir-glucuronide. Thus, the data indicate that the major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation.
Biological Half-Life
9 hours
The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter alpha-phase half-life (approximetly1 hour) accounting for much of the AUC.
Toxicity/Toxicokinetics
Hepatotoxicity
In large clinical trials, therapy with raltegravir was associated with alanine aminotransferase (ALT) elevations in up to 10% and elevations of greater than 5 times the upper limit of normal (ULN) in 3% to 4% of patients, but these rates were similar to those in comparator groups receiving matched background optimized antiretroviral therapy without raltegravir. These elevations were not associated with clinical symptoms and generally did not require dose modification. There have been no published reports of clinically apparent cases of liver injury attributed to raltegravir. Nevertheless, the product label for raltegravir mentions hepatitis and hepatic failure as a potential adverse reactions, but without specific details. Raltegravir has also been linked to instances of Stevens Johnson syndrome and drug hypersensitivity reactions, which can be accompanied by hepatic involvement. Finally, initiation of antiretroviral therapy with raltegravir can result in the immune reconstitution syndrome which may cause a worsening or flare of an accompanying chronic hepatitis B or C in coinfected individuals.
Likelihood score: E* (unproven but suspected cause of clinically apparent liver injury).
Effects During Pregnancy and Lactation
◉ Summary of Use during Lactation
Limited information indicates that maternal doses of up to 1200 mg daily of raltegravir produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants. Achieving and maintaining viral suppression with antiretroviral therapy decreases breastfeeding transmission risk to less than 1%, but not zero. Individuals with HIV who are on antiretroviral therapy with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision. If a viral load is not suppressed, banked pasteurized donor milk or formula is recommended.
◉ Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
◉ Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Protein Binding
83%
Interactions
Pharmacokinetic interaction with omeprazole (substantially increased raltegravir peak plasma concentrations and area under the concentration-time curve (AUC)).
Pharmacokinetic interaction with rifabutin (increased raltegravir peak plasma concentrations and AUC).
Pharmacokinetic interaction with rifampin (decreased raltegravir plasma concentrations and AUC); rifampin is a strong inducer of UGT 1A1. If raltegravir is used in adults receiving rifampin, dosage of raltegravir film-coated tablets should be increased ... twice daily and patients monitored closely for virologic response.
Concomitant use of raltegravir and rifapentine is not recommended. HIV-infected tuberculosis patients treated with rifapentine have a higher rate of tuberculosis relapse than those treated with other rifamycin-based tuberculosis regimens; an alternative antimycobacterial agent is recommended in HIV-infected patients.
For more Interactions (Complete) data for Raltegravir (17 total), please visit the HSDB record page.
References

[1]. Molecular mechanisms of retroviral integrase inhibition and the evolution of viral resistance. Proc Natl Acad Sci U S A, 2010. 107(46): p. 20057-62.

[2]. Combined Medication of Antiretroviral Drugs Tenofovir Disoproxil Fumarate, Emtricitabine, and Raltegravir Reduces Neural Progenitor Cell Proliferation In Vivo and In Vitro. J Neuroimmune Pharmacol. 2017 Dec;12(4):682-692.

[3]. Raltegravir: the first HIV type 1 integrase inhibitor. Clin Infect Dis. 2009 Apr 1;48(7):931-9.

[4]. Divalent metals and pH alter raltegravir disposition in vitro. Antimicrob Agents Chemother. 2012 Jun;56(6):3020-6.

[5]. Structural and functional analyses of the second-generation integrase strand transfer inhibitor dolutegravir (S/GSK1349572). Mol Pharmacol. 2011 Oct;80(4):565-72.

[6]. Response of a simian immunodeficiency virus (SIVmac251) to raltegravir: a basis for a new treatment for simian AIDS and an animal model for studying lentiviral persistence during antiretroviral therapy. Retrovirology, 2010. 7: p. 21.

Additional Infomation
Raltegravir is a pyrimidone that is pyrimidin-4(3H)-one in which the hydrogens at positions 2, 3, 5 and 6 are replaced by 2-[(5-methyl-1,3,4-oxadiazole-2-carbonyl)amino]propan-2-yl, methyl, hydroxy, and N-[(4-fluorophenyl)methyl]aminoacyl groups, respectively. It is an antiretroviral drug used for treatment of HIV infection. It has a role as an antiviral drug and a HIV-1 integrase inhibitor. It is a 1,2,4-oxadiazole, a dicarboxylic acid amide, a member of monofluorobenzenes, a pyrimidone, a hydroxypyrimidine and a secondary carboxamide.
Raltegravir is an antiretroviral drug produced by Merck & Co., used to treat HIV infection. It received approval by the U.S. Food and Drug Administration (FDA) on 12 October 2007, the first of a new class of HIV drugs, the integrase inhibitors, to receive such approval.
Raltegravir is a Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor. The mechanism of action of raltegravir is as a HIV Integrase Inhibitor.
Raltegravir is an integrase inhibitor, the first of the class of antiviral agents active against the human immunodeficiency virus (HIV) that targets the viral integrase. Raltegravir is used in combination with other antiretroviral agents in the treatment of HIV infection. Raltegravir has not been linked convincingly to serum aminotransferase elevations during therapy or to episodes of acute, clinically apparent liver injury.
Raltegravir has been reported in Stachybotrys chartarum with data available.
Raltegravir is a small molecule with activity against human immunodeficiency virus (HIV). Raltegravir is an integrase inhibitor that blocks the integration of the viral genome into the host DNA, a critical step in the pathogenesis of HIV.
A pyrrolidinone derivative and HIV INTEGRASE INHIBITOR that is used in combination with other ANTI-HIV AGENTS for the treatment of HIV INFECTION.
See also: Raltegravir Potassium (has salt form).
Drug Indication
For the treatment of HIV-1 infection in conjunction with other antiretrovirals.
FDA Label
Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.
Treatment of human immunodeficiency virus (HIV-1) infection
Mechanism of Action
Raltegravir inhibits HIV integrase to prevent the viral genome being incorporated into the human genome. Raltegravir is primarily metabolized by glucuronidation.
Raltegravir inhibits the catalytic activity of HIV-1 integrase, an HIV-1 encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of unintegrated linear HIV-1 DNA into the host cell genome preventing the formation of the HIV-1 provirus. The provirus is required to direct the production of progeny virus, so inhibiting integration prevents propagation of the viral infection. Raltegravir did not significantly inhibit human phosphoryltransferases including DNA polymerases alpha, beta, and gamma.
Therapeutic Uses
Pyrrolidinones
ISENTRESS (raltegravir) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. /Included in US product label/
ISENTRESS (raltegravir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older and weighing at least 10 kg. /Included in US product label/
/EXPERIMENTAL THER/ /Investigators/ describe five patients with HIV-2 infection (four antiretroviral-experienced and one antiretroviral-naive) treated with a regimen containing raltegravir. All responded to treatment as demonstrated by viral load and CD4(+) T-cell count monitoring. /This/ series confirms the clinical effectiveness of raltegravir in HIV-2-infected patients when given with other antiretrovirals to which the virus is susceptible.
/EXPERIMENTALTHER VET/ Feline leukemia virus (FeLV) is a gammaretrovirus that is a significant cause of neoplastic-related disorders affecting cats worldwide. Treatment options for FeLV are limited, associated with serious side effects, and can be cost-prohibitive. The development of drugs used to treat a related retrovirus, human immunodeficiency virus type 1 (HIV-1), has been rapid, leading to the approval of five drug classes. Although structural differences affect the susceptibility of gammaretroviruses to anti-HIV drugs, the similarities in mechanism of replication suggest that some anti-HIV-1 drugs may also inhibit FeLV. This study demonstrates the anti-FeLV activity of four drugs approved by the US FDA (Food and Drug Administration) at non-toxic concentrations. Of these, tenofovir and raltegravir are anti-HIV-1 drugs, while decitabine and gemcitabine are approved to treat myelodysplastic syndromes and pancreatic cancer, respectively, but also have anti-HIV-1 activity in cell culture. Our results indicate that these drugs may be useful for FeLV treatment and should be investigated for mechanism of action and suitability for veterinary use.
Drug Warnings
Severe, potentially life-threatening skin reactions have been reported, including some fatalities. Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction (including hepatic failure) have occurred.
Raltegravir and any other suspect agents should be discontinued immediately if signs or symptoms of severe skin or hypersensitivity reactions occur, including (but not limited to) severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, or angioedema. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. A life-threatening reaction could occur if there is a delay in discontinuing raltegravir or other suspect agents after the onset of severe rash.
During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium, M. tuberculosis, cytomegalovirus (CMV), Pneumocystis jiroveci (formerly P. carinii), varicella-zoster virus (VZV)); this may necessitate further evaluation and treatment. Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome) have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of antiretroviral therapy.
Individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine should be advised that raltegravir chewable tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine. Each 25-mg chewable tablet provides approximately 0.05 mg of phenylalanine and each 100-mg chewable tablet provides approximately 0.1 mg of phenylalanine.
For more Drug Warnings (Complete) data for Raltegravir (12 total), please visit the HSDB record page.
These protocols are for reference only. InvivoChem does not independently validate these methods.
Physicochemical Properties
Molecular Formula
C20H21FN6O5
Molecular Weight
444.42
Exact Mass
444.155
CAS #
518048-05-0
Related CAS #
Raltegravir potassium;871038-72-1;Raltegravir sodium;1292804-07-9;Raltegravir-d4;2712343-38-7
PubChem CID
54671008
Appearance
White to off-white solid powder
Density
1.5±0.1 g/cm3
Index of Refraction
1.651
LogP
-0.68
Hydrogen Bond Donor Count
3
Hydrogen Bond Acceptor Count
9
Rotatable Bond Count
6
Heavy Atom Count
32
Complexity
836
Defined Atom Stereocenter Count
0
InChi Key
CZFFBEXEKNGXKS-UHFFFAOYSA-N
InChi Code
InChI=1S/C20H21FN6O5/c1-10-25-26-17(32-10)16(30)24-20(2,3)19-23-13(14(28)18(31)27(19)4)15(29)22-9-11-5-7-12(21)8-6-11/h5-8,28H,9H2,1-4H3,(H,22,29)(H,24,30)
Chemical Name
N-[2-[4-[(4-fluorophenyl)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxopyrimidin-2-yl]propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
Synonyms
MK-0518; MK0518; MK 0518; MK-0518; Raltegravir; trade name: Isentress
HS Tariff Code
2934.99.9001
Storage

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

Note: This product requires protection from light (avoid light exposure) during transportation and storage.
Shipping Condition
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
Solubility Data
Solubility (In Vitro)
DMSO: 88 mg/mL (198.0 mM)
Water:<1 mg/mL
Ethanol:<1 mg/mL
Solubility (In Vivo)
Solubility in Formulation 1: ≥ 2.5 mg/mL (5.63 mM) (saturation unknown) in 10% DMSO + 40% PEG300 + 5% Tween80 + 45% Saline (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 400 μL PEG300 and mix evenly; then add 50 μL Tween-80 to the above solution and mix evenly; then add 450 μL normal saline to adjust the volume to 1 mL.
Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution.

Solubility in Formulation 2: ≥ 2.5 mg/mL (5.63 mM) (saturation unknown) in 10% DMSO + 90% (20% SBE-β-CD in Saline) (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 900 μL of 20% SBE-β-CD physiological saline solution and mix evenly.
Preparation of 20% SBE-β-CD in Saline (4°C,1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution.

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Solubility in Formulation 3: ≥ 2.5 mg/mL (5.63 mM) (saturation unknown) in 10% DMSO + 90% Corn Oil (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 900 μL of corn oil and mix evenly.


Solubility in Formulation 4: 30% PEG400+0.5% Tween80+5% Propylene glycol : 30 mg/mL

 (Please use freshly prepared in vivo formulations for optimal results.)
Preparing Stock Solutions 1 mg 5 mg 10 mg
1 mM 2.2501 mL 11.2506 mL 22.5012 mL
5 mM 0.4500 mL 2.2501 mL 4.5002 mL
10 mM 0.2250 mL 1.1251 mL 2.2501 mL

*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.

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Method for preparing DMSO stock solution mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.

Method for preparing in vivo formulation:Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O,mix and clarify.

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Clinical Trial Information
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
CTID: NCT01854762
Phase: Phase 2/Phase 3    Status: Terminated
Date: 2024-10-15
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
CTID: NCT02140255
Phase: Phase 1/Phase 2    Status: Recruiting
Date: 2024-08-09
Combination Antiretroviral Therapy (cART) for PBC
CTID: NCT03954327
Phase: Phase 2    Status: Completed
Date: 2024-02-16
Research In Viral Eradication of HIV Reservoirs
CTID: NCT02336074
Phase: Phase 2    Status: Completed
Date: 2023-10-23
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
CTID: NCT05648201
Phase: Phase 4    Status: Recruiting
Date: 2023-04-10
View More

Raltegravir for HAM/TSP
CTID: NCT01867320
PhaseEarly Phase 1    Status: Completed
Date: 2023-03-30


Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)
CTID: NCT05751031
Phase:    Status: Recruiting
Date: 2023-03-02
Population Pharmacokinetics of Antiretroviral in Children
CTID: NCT03194165
Phase:    Status: Completed
Date: 2023-02-21
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
CTID: NCT00594646
Phase: Phase 4    Status: Completed
Date: 2022-10-25
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
CTID: NCT00042289
Phase:    Status: Completed
Date: 2022-07-22
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
CTID: NCT01231516
Phase: Phase 3    Status: Completed
Date: 2022-03-15
Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants
CTID: NCT01828073
Phase:    Status: Completed
Date: 2021-11-08
Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection
CTID: NCT01780831
Phase: Phase 1    Status: Completed
Date: 2021-11-05
Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB
CTID: NCT01751568
Phase: Phase 1/Phase 2    Status: Completed
Date: 2021-11-05
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
CTID: NCT00537394
Phase: Phase 3    Status: Completed
Date: 2021-11-04
Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load
CTID: NCT00515827
Phase: Phase 2    Status: Completed
Date: 2021-11-04
Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)
CTID: NCT00660972
Phase: Phase 1    Status: Completed
Date: 2021-11-01
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
CTID: NCT03374358
Phase: Phase 4    Status: Completed
Date: 2021-09-05
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
CTID: NCT01147107
Phase: Phase 4    Status: Completed
Date: 2021-08-13
Study of Options for Second-Line Effective Combination Therapy (SELECT)
CTID: NCT01352715
Phase: Phase 3    Status: Completed
Date: 2021-08-05
Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection
CTID: NCT03205566
Phase: Phase 4    Status: Completed
Date: 2021-03-16
Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen
CTID: NCT00738569
Phase: N/A    Status: Completed
Date: 2021-01-19
Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir
CTID: NCT01288417
Phase: Phase 1    Status: Completed
Date: 2020-12-01
The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER)
CTID: NCT01246804
Phase: Phase 1    Status: Completed
Date: 2020-11-30
Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen
CTID: NCT02577042
Phase: Phase 4    Status: Completed
Date: 2020-10-29
Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.
CTID: NCT01779687
Phase: Phase 1    Status: Completed
Date: 2020-10-20
Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL).
CTID: NCT01978782
Phase: Phase 1    Status: Completed
Date: 2020-10-19
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
CTID: NCT00665717
Phase: Phase 1    Status: Completed
Date: 2020-10-19
Pharmacokinetic Study on Raltegravir and Lamotrigine
CTID: NCT00618241
Phase: Phase 1    Status: Completed
Date: 2020-10-19
Raltegravir Intensification in HIV-infected Patients
CTID: NCT00631449
Phase: Phase 4    Status: Completed
Date: 2020-08-17
Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME STUDY
CTID: NCT03029689
Phase: Phase 3    Status: Completed
Date: 2020-07-27
Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
CTID: NCT00752856
Phase: Phase 2    Status: Completed
Date: 2020-07-22
Pharmacokinetics of Low Dose Raltegravir
CTID: NCT01159132
Phase: Phase 2    Status: Completed
Date: 2020-07-17
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine
CTID: NCT00808002
Phase: Phase 3    Status: Completed
Date: 2020-01-31
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
CTID: NCT01618305
Phase: Phase 4    Status: Completed
Date: 2020-01-30
Pilot Study to Compare the Pharmacokinetics Parameters in Plasma and Intracellular of Raltegravir Administered Once a Day in Adult Patients Infected With HIV
CTID: NCT00995241
Phase: Phase 4    Status: Completed
Date: 2019-12-05
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
CTID: NCT01335620
Phase: Phase 4    Status: Completed
Date: 2019-11-20
Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals
CTID: NCT01293123
Phase: N/A    Status: Terminated
Date: 2019-10-31
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
CTID: NCT00982553
Phase: Phase 1    Status: Completed
Date: 2019-10-11
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
CTID: NCT03667547
Phase: Phase 4    Status: Completed
Date: 2019-10-02
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.
CTID: NCT01258374
Phase:    Status: Completed
Date: 2019-09-27
Bone and Body Comp: A Sub Study of the SECOND-LINE Study
CTID: NCT01513122
Phase: Phase 4    Status: Completed
Date: 2019-09-04
A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen
CTID: NCT00931463
Phase: Phase 4    Status: Completed
Date: 2019-09-04
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation Mediators, Cardiovascular Risk and Neurocognitive Disorders in HIV Infected Patients Previously Effectively Treated
CTID: NCT01529749
Phase: Phase 4    Status: Completed
Date: 2019-08-02
First-Line Treatment for HIV-2
CTID: NCT02150993
Phase: Phase 2/Phase 3    Status: Completed
Date: 2019-07-22
A Prospective, Open-label Trial of Two ABC/3TC Based Regimens in Late Presenter naïve Patients (CD4 <200 Cells/µL)
CTID: NCT01900106
Phase: Phase 3    Status: Completed
Date: 2019-04-23
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
CTID: NCT02116660
Phase: Phase 2    Status: Terminated
Date: 2019-04-08
A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure
CTID: NCT01641367
Phase: Phase 4    Status: Completed
Date: 2019-03-15
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
CTID: NCT01989910
Phase: Phase 4    Status: Completed
Date: 2019-02-25
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
CTID: NCT03537404
Phase: Phase 1    Status: Completed
Date: 2019-02-19
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study
CTID: NCT03732625
Phase: Phase 4    Status: Unknown status
Date: 2019-02-15
Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)
CTID: NCT02131233
Phase: Phase 3    Status: Completed
Date: 2019-01-30
Effects of Raltegravir Based Regimen on Platelet Reactivity, Platelet-monocyte Aggregation and Immune Activation
CTID: NCT02383355
Phase: Phase 4    Status: Completed
Date: 2019-01-10
Raltegravir Versus Efavirenz in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis
CTID: NCT02273765
Phase: Phase 3    Status: Completed
Date: 2018-12-31
Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults
CTID: NCT02218320
Phase:    Status: Completed
Date: 2018-12-26
Effect of Raltegravir on Endothelial Function in HIV-Infected Patients
CTID: NCT00843713
Phase: Phase 4    Status: Completed
Date: 2018-12-12
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
CTID: NCT01384734
Phase: Phase 2    Status: Completed
Date: 2018-11-14
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
CTID: NCT00830804
Phase: Phase 2    Status: Completed
Date: 2018-11-08
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
CTID: NCT01227824
Phase: Phase 3    Status: Completed
Date: 2018-10-09
Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500
CTID: NCT02489487
Phase: Phase 1    Status: Completed
Date: 2018-10-04
Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals
CTID: NCT00632970
Phase: Phase 4    Status: Terminated
Date: 2018-08-29
The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)
CTID: NCT02473367
Phase: Phase 1    Status: Completed
Date: 2018-08-27
A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)
CTID: NCT01930045
Phase: Phase 1    Status: Completed
Date: 2018-08-24
A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)
CTID: NCT01717287
Phase: Phase 2    Status: Completed
Date: 2018-08-21
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
CTID: NCT00529243
Phase: Phase 3    Status: Completed
Date: 2018-08-07
Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen
CTID: NCT03333083
Phase: Phase 3    Status: Unknown status
Date: 2018-07-31
Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM
CTID: NCT03311945
Phase: Phase 3    Status: Unknown status
Date: 2018-07-31
Raltegravir in the Swiss HIV Cohort Study
CTID: NCT00904644
Phase:    Status: Completed
Date: 2018-06-06
A Key Link for Transmission Prevention
CTID: NCT01450189
Phase: N/A    Status: Completed
Date: 2018-04-19
Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV
CTID: NCT01601626
Phase: Phase 2    Status: Terminated
Date: 2018-02-13
Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load
CTID: NCT01620736
Phase: Phase 2    Status: Withdrawn
Date: 2018-01-24
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study
CTID: NCT00537966
Phase: N/A    Status: Recruiting
Date: 2017-11-08
A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects
CTID: NCT01101893
Phase: Phase 1    Status: Completed
Date: 2017-09-11
Measurement of Plasma and Intracellular Concentrations of Raltegravir
CTID: NCT01214486
Phase: N/A    Status: Completed
Date: 2017-08-21
Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen
CTID: NCT01978743
Phase: N/A    Status: Completed
Date: 2017-07-26
Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection
CTID: NCT01900015
Phase: Phase 4    Status: Completed
Date: 2017-07-25
BRAVO: Background Regimen of Raltegravir on Virologic Outcome
CTID: NCT00751530
Phase:    Status: Completed
Date: 2017-07-02
Effect of Antacids on the Pharmacokinetics of Raltegravir
CTID: NCT00944307
Phase: Phase 1    Status: Completed
Date: 2017-06-28
Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis
CTID: NCT01767701
Phase: Phase 2    Status: Completed
Date: 2017-05-30
Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy
CTID: NCT00661960
Phase: N/A    Status: Completed
Date: 2017-05-30
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
CTID: NCT02302950
Phase:    Status: Unknown status
Date: 2017-05-22
EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma
CTID: NCT01000285
Phase: Phase 1/Phase 2    Status: Completed
Date: 2017-03-28
A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)
CTID: NCT01622673
Phase: Phase 1    Status: Completed
Date: 2017-03-21
A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)
CTID: NCT00369941
Phase: Phase 3    Status: Completed
Date: 2017-03-21
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
CTID: NCT01000818
Phase: Phase 1    Status: Completed
Date: 2017-03-21
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
CTID: NCT00443703
Phase: Phase 3    Status: Terminated
Date: 2017-03-21
Raltegravir as Early Therapy in African-Americans Living With HIV Study
CTID: NCT00667433
Phase: Phase 1    Status: Completed
Date: 2017-03-03
Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection
CTID: NCT01114425
Phase: Phase 3    Status: Completed
Date: 2017-02-23
Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa
CTID: NCT02025868
Phase: Phase 2    Status: Unknown status
Date: 2017-02-17
Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia
CTID: NCT00618371
Phase: N/A    Status: Completed
Date: 2017-02-01
RAL+ATV/r in Comparison With TDF/FTC (or 3TC) +ATV/r in HIV Infected Patients
CTID: NCT01829802
Phase: Phase 4    Status: Unknown status
Date: 2017-01-24
Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
CTID: NCT01245101
Phase: Phase 4    Status: Terminated
Date: 2016-12-23
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
CTID: NCT01285050
Phase: Phase 4    Status: Completed
Date: 2016-11-29
A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers
CTID: NCT01531647
Phase: Phase 1    Status: Completed
Date: 2016-11-02
Raltegravir Switch Study to Reduce Liver Fibrosis Progression in HIV-Hepatitis C Co-infection
CTID: NCT01231685
Phase: Phase 2    Status: Completed
Date: 2016-09-21
Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir
CTID: NCT02097108
Phase: Phase 2    Status: Completed
Date: 2016-09-13
Renal Transplantation and Raltegravir in HIV-Infected Patients
CTID: NCT01453192
Phase: Phase 3    Status: Completed
Date: 2016-07-12
A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV
CTID: NCT01448486
Phase: Phase 4    Status: Terminated
Date: 2016-06-27
Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection
CTID: NCT00734344
Phase: N/A    Status: Completed
Date: 2016-05-30
Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
CTID: NCT00708162
Phase: Phase 3    Status: Completed
Date: 2016-05-30
A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)
CTID: NCT01213316
Phase:    Status: Completed
Date: 2016-05-23
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)
CTID: NCT00377065
Phase:    Status: Approved for marketing
Date: 2016-04-22
Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy
CTID: NCT01825031
Phase: Phase 3    Status: Completed
Date: 2016-04-20
Effects of Intensive cART During Acute/Early HIV Infection
CTID: NCT01154673
Phase: Phase 2/Phase 3    Status: Completed
Date: 2016-04-05
The Effect of Antacids and Multivitamins on Raltegravir
CTID: NCT01784302
Phase: Phase 1    Status: Completed
Date: 2016-02-25
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
CTID: NCT01214759
PhasePh
EFFICACY AND SAFETY OF A SIMPLIFICATION STRATEGY BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS OPTIMIZED TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS CARRYING ARCHIVED MULTIDRUG RESISTANCE MUTATIONS
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2018-09-04
A randomized, open, parallel design study to evaluate the effect on liver fat, adipose tissue and metabolic parameters when switching a protease inhibitor or efavirenz to once daily raltegravir in HIV-infected patients with body mass index over 25 kg/m2 and with at least one metabolic syndrome component.
CTID: null
Phase: Phase 4    Status: Completed
Date: 2017-11-29
Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of 3TC (150 mg BID) plus Raltegravir (400 mg BID) switching to 3TC (300 mg QD) plus Raltegravir (1200 mg QD) : Roll-over study of the RALAM clinical trial (NCT02284035)
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2017-10-11
Phase 3b, single arm, single site simplification study with dual therapy including 3TC (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected atients experiencing inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions with their current regimen. RALAM-II study
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2017-10-04
Randomized, open-label and multicentric trial evaluating the non-inferiority of antiretroviral treatment taken 4 consecutive days per week versus continuous therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral therapy
CTID: null
Phase: Phase 3    Status: Completed
Date: 2017-07-02
The time to protection and adherence requirements of Raltegravir with or without lamivudine in protection from HIV infection
CTID: null
Phase: Phase 4    Status: Completed
Date: 2017-04-28
Randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of Raltegravir intensification (1.200 mg QD) on the gut microbiota of chronically HIV-1 infected subject over time: THE RAGTIME STUDY
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2017-03-29
Raltegravir-based regimen versus raltegravir-based regimen plus atorvastatin for reducing ?inflamaging? (aging-related complication) in HIV-infected patients older than 60 years.
CTID: null
Phase: Phase 4    Status: Completed
Date: 2015-09-30
A non-comparative phase II trial evaluating the capacity of the dual combination raltegravir/etravirine to maintain virological success in HIV-1 infected patients of at least 45 years of age with an HIV-RNA plasma viremia below 50 copies/mL
CTID: null
Phase: Phase 2    Status: Completed
Date: 2015-05-31
An open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of two dolutegravir-based simplification strategies in HIV-infected patients with prolonged virological suppression
CTID: null
Phase: Phase 4    Status: Completed
Date: 2015-04-23
A phase IV, open-label three-arm study investigating the impact of a combination of tenofovir disoproxil fumarate/emtricitabine with raltegravir or dolutegravir or elvitegravir/cobicistat on renal tubular function and renal transporters in HIV-1 antiretroviral naïve patients
CTID: null
Phase: Phase 4    Status: Completed
Date: 2015-01-26
RIVER - Research In Viral Eradication of HIV Reservoirs, A two-arm (proof of concept) randomised phase II trial
CTID: null
Phase: Phase 2    Status: GB - no longer in EU/EEA
Date: 2015-01-13
The Central Nervous System Effects of Two Different HIV-Integrase Inhibitor Containing Antiretroviral Regimens.
CTID: null
Phase: Phase 4    Status: Completed
Date: 2014-11-27
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects
CTID: null
Phase: Phase 3    Status: Completed
Date: 2014-05-16
Switching from regimens consisting of a RTV -boosted protease inhibitor plus TDF/ FTC to a combination of RAltegravir pluis NevIrapine and IAmivudine in HIV patients with suppressed viremia and and impaired renal function (RANIA study)
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2014-05-16
Evaluation of the pharmacokinetic properties and the tolerance of raltegravir during the third trimester of pregnancy
CTID: null
Phase: Phase 2    Status: Completed
Date: 2014-02-06
One arm, Open label, Interventional, non-comparative Study to assess Changes in Lipids and Lipoproteins in HIV infected Women with Hyperlipidemia after Switch from boosted Protease Inhibitors to Raltegravir
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2013-12-02
Cambios esteatosis hepática debido a cambiar efavirens por RALTEGRAVIR conjunta de dos análogos de nucleósidos en pacientes coinfectados por VIH / VHC,: Estudio Steral
CTID: null
Phase: Phase 4    Status: Completed
Date: 2013-09-09
“Switching HIV-positive Women With Undetectable Viremia on Tenofovir/Emtricitabine plus Boosted Atazanavir to RALtegravir (400 mg twice-daily) plus Boosted ATazanavir (300/100 mg once-daily): A Pilot Randomized Clinical Trial Investigating 48-weeks Changes in Bone Mineral Density”
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2013-08-17
Randomized,multicenter,open-label, study of monoterapy with darunavir/ritonavir or lopinavir/ritonavir vs standard of care in virologically suppressed HIV-infected patients.
CTID: null
Phase: Phase 3    Status: Completed
Date: 2013-06-20
A phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI
CTID: null
Phase: Phase 2    Status: Completed
Date: 2013-01-16
Effects of losartan and antiretroviral regimen containing raltegravir in fibrosis inflammation mediators, cardiovascular risk and neurocognitive disorders in HIV infected patients previously effectively treated.
CTID: null
Phase: Phase 4    Status: Completed
Date: 2012-01-16
Comparison of two antiretroviral regimens in HIV Post-exposure Prophylaxis: TDF-FTC (Truvada®) + Lopinavir/ritonavir (kaletra®) versus TDF-FTC (Truvada®) + raltegravir (Isentress®). A prospective, randomized, open clinical trial.
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2012-01-05
A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of lopinavir-ritonavir to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2011-11-29
Impact of Raltegravir Intensification on HIV-1-infected Subjects with Complete Viral Suppression under Monotherapy with Protease Inhibitors. A 24-week controlled, open-label, proof-of-concept pilot clinical trial.
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2011-11-22
Studio PKCT - Pharmacokinetics of chemotherapy when given concurrently with antiretroviral (Protocol no. CSL01).
CTID: null
Phase: Phase 4    Status: Completed
Date: 2011-10-20
An Open-Label, Randomized Study Evaluating a Switch from a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors plus any Third Agent to either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on their Present Treatment Regimen (the HARNESS study).
CTID: null
Phase: Phase 4    Status: Completed
Date: 2011-08-01
Studio degli effetti immuno-virologici dell’interruzione di Maraviroc nei pazienti che stanno fallendo un regime contenente Maraviroc
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2011-03-22
A e.quer

Biological Data
  • Raltegravir (MK-0518)

    SIVmac251 susceptibility to raltegravir in tissue culture. Retrovirology. 2010 Mar 16;7:21.
  • Raltegravir (MK-0518)

    Effect of raltegravir (RAL), alone and in combination with PMPA and FTC, on viral load (panel A) and CD4 counts (panel B) in SIVmac251-infected macaques (Group 1). Retrovirology. 2010 Mar 16;7:21.
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