Trial reportJournal of acquired immune deficiency syndromes (1999)2010
Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a Phase II study.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Long-term safety from the raltegravir clinical development program.Current HIV research · 2011Pooled it
- Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study.AIDS research and human retroviruses · 2013Trial
- Pharmacokinetics and pharmacodynamics of once-daily versus twice-daily raltegravir in treatment-naive HIV-infected patients.Antimicrobial agents and chemotherapy · 2012Trial
- Pharmacokinetic effects of coadministration of lersivirine with raltegravir or maraviroc in healthy subjects.Antimicrobial agents and chemotherapy · 2012Trial
- Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial.Drugs in R&D · 2011Trial
- Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2010Trial
- 2022 update of the drug resistance mutations in HIV-1.Topics in antiviral medicine · 2022Article
- Genetic Diversity and Low Therapeutic Impact of Variant-Specific Markers in HIV-1 Pol Proteins.Frontiers in microbiology · 2022Article
- Evidence for Disruption of MgFrontiers in molecular biosciences · 2020Article
- 2019 update of the drug resistance mutations in HIV-1.Topics in antiviral medicine · 2019Article
- Prevalence of Human Immunodeficiency Virus-1 Integrase Strand Transfer Inhibitor Resistance in British Columbia, Canada Between 2009 and 2016: A Longitudinal Analysis.Open forum infectious diseases · 2019Article
- Long-term tolerability and effectiveness of raltegravir in Japanese patients: Results from post-marketing surveillance.PloS one · 2019Observational
- Raltegravir-Induced Adaptations of the HIV-1 Integrase: Analysis of Structure, Variability, and Mutation Co-occurrence.Frontiers in microbiology · 2019Article
- Absence of HIV-1 Drug Resistance Mutations Supports the Use of Dolutegravir in Uganda.AIDS research and human retroviruses · 2018Article
- P-glycoprotein (ABCB1) activity decreases raltegravir disposition in primary CD4+P-gphigh cells and correlates with HIV-1 viral load.The Journal of antimicrobial chemotherapy · 2016Article
- Hepatic safety and tolerability of raltegravir among HIV patients coinfected with hepatitis B and/or C.Antiviral therapy · 2014Article
- Raltegravir has a low propensity to cause clinical drug interactions through inhibition of major drug transporters: an in vitro evaluation.Antimicrobial agents and chemotherapy · 2014Article
- Long-term efficacy and safety of raltegravir in the management of HIV infection.Infection and drug resistance · 2014Review
- Initiation of antiretroviral therapy.Indian journal of sexually transmitted diseases and AIDS · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
backgroundRaltegravir in combination therapy has demonstrated potent suppression of HIV-1 with a favorable safety profile. This report provides 96-week efficacy and safety data from Protocol 005, a Phase II study.
methodsHIV-infected patients with very limited treatment options and failing antiretroviral therapy were randomized to raltegravir 200, 400, or 600 mg or placebo b.i.d., plus optimized background therapy for >or=24 weeks; all patients were then offered open-label raltegravir 400 mg b.i.d. Efficacy measurements included changes in viral load and CD4 count from baseline and percent of patients with HIV-1 RNA <400 and <50 copies/mL.
resultsOne hundred and thirty-three patients received raltegravir and 45 received placebo. No dose-dependent differentiation in the safety or antiviral activity of raltegravir was observed during the double-blind phase. For the combined raltegravir groups, mean change in viral load from baseline was -1.60 log10 copies/mL at week 48 and -1.38 log10 copies/mL at week 96 (observed failure approach). At week 48, HIV-1 RNA levels were <400 copies/mL in 68% of raltegravir recipients and <50 copies/mL in 55%; these levels were maintained in 55% and 48% of raltegravir recipients, respectively, at week 96 (noncompleter = failure). There were few discontinuations of raltegravir (4%) due to adverse events.
conclusionsIn patients with limited treatment options, raltegravir with OBT had a potent and sustained antiretroviral effect and was generally well tolerated through 96 weeks.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.