ISENTRESS SUMMARY
ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor.
ISENTRESS 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-naïve adult patients or pediatric patients.
There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.
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NEWS HIGHLIGHTS
Published Studies Related to Isentress (Raltegravir)
Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. [2009.09.05]
BACKGROUND: Use of raltegravir with optimum background therapy is effective and well tolerated in treatment-experienced patients with multidrug-resistant HIV-1 infection. We compared the safety and efficacy of raltegravir with efavirenz as part of combination antiretroviral therapy for treatment-naive patients... INTERPRETATION: Raltegravir-based combination treatment had rapid and potent antiretroviral activity, which was non-inferior to that of efavirenz at week 48. Raltegravir is a well tolerated alternative to efavirenz as part of a combination regimen against HIV-1 in treatment-naive patients. FUNDING: Merck.
Minimal effects of ritonavir and efavirenz on the pharmacokinetics of raltegravir. [2008.12]
Raltegravir is a novel human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor with potent in vitro activity against HIV-1 (95% inhibitory concentration = 31 nM in 50% human serum). The possible effects of ritonavir and efavirenz on raltegravir pharmacokinetics were separately examined...
Lack of a significant drug interaction between raltegravir and tenofovir. [2008.09]
Raltegravir is a novel human immunodeficiency virus type 1 (HIV-1) integrase inhibitor with potent in vitro activity (95% inhibitory concentration of 31 nM in 50% human serum)... Raltegravir and TDF may be coadministered without dose adjustments.
Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. [2008.07.24]
BACKGROUND: We evaluated the efficacy of raltegravir and the development of viral resistance in two identical trials involving patients who were infected with human immunodeficiency virus type 1 (HIV-1) with triple-class drug resistance and in whom antiretroviral therapy had failed... CONCLUSIONS: When combined with an optimized background regimen in both studies, a consistently favorable treatment effect of raltegravir over placebo was shown in clinically relevant subgroups of patients, including those with baseline characteristics that typically predict a poor response to antiretroviral therapy: a high HIV-1 RNA level, low CD4 cell count, and low genotypic or phenotypic sensitivity score. (ClinicalTrials.gov numbers, NCT00293267 and NCT00293254.) 2008 Massachusetts Medical Society
Raltegravir with optimized background therapy for resistant HIV-1 infection. [2008.07.24]
BACKGROUND: Raltegravir (MK-0518) is an inhibitor of human immunodeficiency virus type 1 (HIV-1) integrase active against HIV-1 susceptible or resistant to older antiretroviral drugs... CONCLUSIONS: In HIV-infected patients with limited treatment options, raltegravir plus optimized background therapy provided better viral suppression than optimized background therapy alone for at least 48 weeks. (ClinicalTrials.gov numbers, NCT00293267 and NCT00293254.) 2008 Massachusetts Medical Society
Clinical Trials Related to Isentress (Raltegravir)
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA) [Recruiting]
Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression [Recruiting]
An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART
regimen with persistent HIV-1 viral suppression could increase the slope of decay of the
HIV-1 latent reservoir.
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.
Safety and Effectiveness of Raltegravir (MK-0518) in Treatment-Experienced, HIV-Infected Children and Adolescents [Recruiting]
Integrase is a protein that HIV needs in order to reproduce in the human body. Raltegravir
is a new drug that prevents integrase from working properly. This drug has been tested for
safety and effectiveness in adults but not in children. The purpose of this study is to
determine the safety and effectiveness of raltegravir in treatment-experienced HIV-infected
children and adolescents.
Buprenorphine/Raltegravir Pharmacokinetic Interaction Study [Recruiting]
The main purpose of this protocol is to study the effect of an HIV medication known as
Raltegravir on Buprenorphine in people who have been receiving the same dose of
Buprenorphine for at least 3 weeks before study entry. This will be determined by giving
Raltegravir along with Buprenorphine and by measuring the amount of Raltegravir and
Buprenorphine in the blood. The investigators will also learn about the effects of
Buprenorphine on Raltegravir and about the safety of taking these two medications together.
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