SynthesisCurrent HIV research2011
Long-term safety from the raltegravir clinical development program.
Synthesis in Current HIV research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00369941 (A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™), which is not on this map. Cited by 19 papers.
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.
A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™
Who cites it
19 citing papers in PubMed, 43 citations in OpenAlex.
- Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial.AIDS research and therapy · 2016Trial
- Nucleoside Reverse Transcriptase Inhibitors Are the Major Class of HIV Antiretroviral Therapeutics That Induce Neuropathic Pain in Mice.International journal of molecular sciences · 2024Article
- Integrase Inhibitors are Associated with Neuropsychiatric Symptoms in Women with HIV.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2023Article
- Integrase Strand Transfer Inhibitor Use and Cancer Incidence in a Large Cohort Setting.Open forum infectious diseases · 2022Article
- Hepatotoxicity of Contemporary Antiretroviral Drugs: A Review and Evaluation of Published Clinical Data.Cells · 2021Review
- Beneficial and Adverse Effects of cART Affect Neurocognitive Function in HIV-1 Infection: Balancing Viral Suppression against Neuronal Stress and Injury.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2021Review
- Review
- HIV Integrase Inhibitor Pharmacogenetics: An Exploratory Study.Clinical drug investigation · 2019Article
- Incidence of cancer and overall risk of mortality in individuals treated with raltegravir-based and non-raltegravir-based combination antiretroviral therapy regimens.HIV medicine · 2018Article
- Central nervous system-penetrating antiretrovirals impair energetic reserve in striatal nerve terminals.Journal of neurovirology · 2017Article
- Association of the HLA-B*53:01 Allele With Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome During Treatment of HIV Infection With Raltegravir.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Article
- Psychiatric Symptoms in Patients Receiving Dolutegravir.Journal of acquired immune deficiency syndromes (1999) · 2017Article
- Neuronal Stress and Injury Caused by HIV-1, cART and Drug Abuse: Converging Contributions to HAND.Brain sciences · 2017Review
- Neurotoxicity in the Post-HAART Era: Caution for the Antiretroviral Therapeutics.Neurotoxicity research · 2016Review
- Neuropsychiatric Effects of HIV Antiviral Medications.Drug safety · 2016Review
- Review
- Population pharmacokinetic analysis and pharmacogenetics of raltegravir in HIV-positive and healthy individuals.Antimicrobial agents and chemotherapy · 2012Article
- Article
- Raltegravir in HIV-1 infection: Safety and Efficacy in Treatment-naïve Patients.Clinical medicine reviews in therapeutics · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRaltegravir has demonstrated potent and durable efficacy and a favorable safety profile in 3 phase III studies in treatment-naïve and treatment-experienced patients with HIV-1 infection. This manuscript provides a review of the raltegravir safety profile using data from these and other studies in the clinical development program.
methodsComprehensive 96-week safety data from STARTMRK (raltegravir versus efavirenz, each with tenofovir/emtricitabine) and BENCHMRK (raltegravir versus placebo, each with optimized background therapy) are summarized. A cumulative meta-analysis of raltegravir 400 mg bid was conducted across the entire development program.
resultsIn STARTMRK, drug-related adverse events (AEs) occurred less frequently with raltegravir than efavirenz. In BENCHMRK, the most common drug-related AEs occurred at generally similar frequencies in both groups. Drug-related serious AEs were uncommon. Rash was observed in raltegravir-treated patients at a higher frequency than placebo but a lower frequency than efavirenz. Depression and immune reconstitution inflammatory syndrome occurred at similar rates for raltegravir and comparators. Isolated elevations of creatine kinase were more common with raltegravir than placebo but occurred without clinical manifestations. The frequency of aminotransferase elevations was greater in patients with viral hepatitis co-infection, but similar in the raltegravir and comparator groups. The relative risk (95% CI) of cancer was 0.75 (0.30, 1.91) indicating no difference between raltegravir and comparator. Overall trends in the cumulative meta-analysis were similar to those observed in the phase III studies.
conclusionsLong-term data from the phase III clinical trials demonstrate that raltegravir was generally well-tolerated in both treatment-naïve and treatment-experienced patients with HIV infection.
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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.