ISENTRESS SUMMARY
ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor.
ISENTRESS is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve 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 pediatric patients.
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NEWS HIGHLIGHTSMedia Articles Related to Isentress (Raltegravir)
Higher-Dose, Once-Daily Raltegravir Regimen for HIV-1
Source: Medscape HIV/AIDS Headlines [2017.09.26]
A 1,200-mg, once-daily regimen of raltegravir, in combination with tenofovir disoproxil fumarate and emtricitabine, is effective in patients with previously untreated HIV-1 infection, according to results from the ONCEMRK trial.
Reuters Health Information
Adverse Events of Raltegravir and Dolutegravir
Source: Medscape HIV/AIDS Headlines [2017.09.25]
Do commonly reported toxic adverse events associated with these drugs factor into the decision to discontinue ART?
AIDS
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.
Clinical Trials Related to Isentress (Raltegravir)
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients [Completed]
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.
Study to Characterize the Pharmacokinetics of Raltegravir in the Gastrointestinal (GI) Tract of Healthy Male Volunteers [Completed]
The purpose of this study is to characterize the way the first commercially available
integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV,
is distributed into the rectal mucosal tissue. This information will generate important
information regarding the drug's penetration into lymphoid tissues that are rapidly depleted
in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for
treating HIV-infected individuals will be designed.
The Effect of Rifapentine on Raltegravir [Completed]
Effect of Antacids on the Pharmacokinetics of Raltegravir [Completed]
The purpose of this study is to test whether there is a drug interaction between raltegravir
(a medicine used to treat the human immunodeficiency virus or HIV) and antacids.
Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men [Completed]
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.
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 >>
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Page last updated: 2017-09-26
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