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Isentress (Raltegravir) - Summary



ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor.

ISENTRESS [Trademark of MERCK & CO., Inc.
All rights reserved]
in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

This indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of ISENTRESS. These studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults.

The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies].

The safety and efficacy of ISENTRESS have not been established in treatment-nave adult patients or pediatric patients.

There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.

See all Isentress indications & dosage >>


Media Articles Related to Isentress (Raltegravir)

Raltegravir Prevents HIV Transmission in Newborns (CME/CE)
Source: MedPage Today OB/Gyn [2015.07.24]
(MedPage Today) -- Small study suggests integrase inhibitor can help prevent mother-to-child infections.

FDA approves diagnostic test to differentiate between types of HIV infection
Source: HIV / AIDS News From Medical News Today [2015.07.24]
The U.S. Food and Drug Administration has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and...

Study finds PrEP use feasible among high-risk groups in US community settings
Source: HIV / AIDS News From Medical News Today [2015.07.22]
A majority of men who have sex with men (MSM) and transgender women (TGW) at high risk for HIV infection took anti-HIV medication for pre-exposure prophylaxis (PrEP), most of the time, in a...

PrEP Roll-out in Botswana Proves Worthy (CME/CE)
Source: MedPage Today OB/Gyn [2015.07.22]
(MedPage Today) -- No HIV infections in initial year-long program.

HPTN 052 demonstrates sustained benefit of early antiretroviral therapy
Source: HIV / AIDS News From Medical News Today [2015.07.21]
Antiretroviral therapy (ART) for HIV infection provides lasting protection against the sexual transmission of the virus from infected men and women to their HIV-uninfected sexual partners...

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Published Studies Related to Isentress (Raltegravir)

Sustained efficacy and safety of raltegravir after 5 years of combination antiretroviral therapy as initial treatment of HIV-1 infection: final results of a randomized, controlled, phase II study (Protocol 004). [2012]
Raltegravir as initial HIV therapy was examined in a double-blind study; 160 patients were randomized to raltegravir (400 mg bid after dose-ranging), 38 to efavirenz, both with tenofovir/lamivudine. At week 240, HIV-RNA remained <50 copies per milliliter in 68.8% (raltegravir) versus 63.2% (efavirenz), and CD4 increases were 302 versus 276 cells per microliter, respectively...

Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial. [2011.09]
OBJECTIVES: To assess the sustainable efficacy and safety of a switch from enfuvirtide to raltegravir in patients with multidrug-resistant HIV infection... CONCLUSIONS: In well-suppressed patients with multidrug-resistant HIV infection, a switch from enfuvirtide to raltegravir is generally well tolerated and has sustained antiviral efficacy when combined with a potent background regimen.

A randomized cross-over study to compare raltegravir and efavirenz (SWITCH-ER study). [2011.07.31]
CONCLUSION: Half of patients previously on a stable EFV preferred to switch to RAL, after double-blind exposure to RAL for 2 weeks. Substitution of EFV by RAL significantly impacted on lipid levels, stress, and anxiety scores.

Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies. [2011.07.17]
OBJECTIVE: We evaluated the long-term efficacy of raltegravir according to HIV-1 subtype (B and non-B) using data from three phase III studies in treatment-experienced (BENCHMRK-1 and 2) and treatment-naive (STARTMRK) HIV-infected patients... CONCLUSION: In phase III studies in treatment-naive and treatment-experienced patients, raltegravir showed comparable and potent clinical efficacy against B and non-B HIV-1 subtypes.

A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response. [2011.04.01]
BACKGROUND: Some human immunodeficiency virus (HIV)-infected individuals are not able to achieve a normal CD4(+) T cell count despite prolonged, treatment-mediated viral suppression. We conducted an intensification study to assess whether residual viral replication contributes to replenishment of the latent reservoir and whether mucosal HIV-specific T cell responses limit the reservoir size... CONCLUSIONS: Low-level viremia is not likely to be a significant cause of suboptimal CD4(+) T cell gains during HIV treatment. CLINICAL TRIALS REGISTRATION: NCT00631449.

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Clinical Trials Related to Isentress (Raltegravir)

Raltegravir Switch for Toxicity or Adverse Events [Recruiting]
This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.

Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1 [Recruiting]
This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.

The Effect of Rifapentine on Raltegravir [Recruiting]

Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients [Recruiting]
This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.

Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men [Recruiting]
The use of anti-HIV drugs following a potential sexual or injecting drug use exposure to HIV in order to try and prevent an exposure from becoming an infection is common. This is called nonoccupational postexposure prophylaxis (NPEP). The likelihood of NPEP succeeding is related to intrinsic qualities of the drugs used which includes at which point in the life cycle of the HIV virus the drugs work, how strong the drugs are against HIV, and how well tolerated the drugs are i. e. what side effects they produce. Many people skip doses during their treatment or abandon their treatment because of side effects. The anti-HIV drug raltegravir works early in the life cycle of the virus i. e. before it integrates with human DNA, is potent against HIV and causes few side effects. These qualities make it an obvious choice for use as a NPEP treatment. In this study 100 HIV negative men will receive raltegravir along with another HIV drug called truvada (commonly used in NPEP) for 28 days after a possible sexual exposure to HIV. They will be monitored closely for adverse events, side effects and for their ability to take the medicine each day for the whole 28 days. The hypothesis in this study states that raltegravir use in NPEP will be safe, well tolerated and result in a high treatment completion rate.

more trials >>

Reports of Suspected Isentress (Raltegravir) Side Effects

Foetal Exposure During Pregnancy (47)Death (38)Maternal Exposure During Pregnancy (36)Anaemia (26)Pyrexia (24)Depression (21)Pneumonia (19)Cytolytic Hepatitis (19)Rash (19)Eosinophilia (19)more >>

Page last updated: 2015-07-24

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