Trial reportAntimicrobial agents and chemotherapy2008
Lack of a significant drug interaction between raltegravir and tenofovir.
Trial report in Antimicrobial agents and chemotherapy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00977756 (IMPAACT P1058A), which is not on this map. Cited by 23 papers, 1 of them a synthesis 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.
IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.
- Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic Review.Clinical pharmacokinetics · 2023Pooled it
- Methotrexate Decreases Tenofovir Exposure in Antiretroviral-Suppressed Individuals Living With HIV.Journal of acquired immune deficiency syndromes (1999) · 2020Trial
- Effects of Tenofovir on the Single-Dose Pharmacokinetics of Intravenous Morinidazole in Healthy Chinese Subjects.Antimicrobial agents and chemotherapy · 2020Trial
- Pharmacokinetics of and short-term virologic response to low-dose 400-milligram once-daily raltegravir maintenance therapy.Antimicrobial agents and chemotherapy · 2012Trial
- Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy.The AAPS journal · 2025Article
- Drug-Drug Interactions Between HIV Antivirals and Concomitant Drugs in HIV Patients: What We Know and What We Need to Know.Pharmaceutics · 2024Review
- Recent Advances in the Development of Integrase Inhibitors for HIV Treatment.Current HIV/AIDS reports · 2020Review
- Probenecid-Boosted Tenofovir: A Physiologically-Based Pharmacokinetic Model-Informed Strategy for On-Demand HIV Preexposure Prophylaxis.CPT: pharmacometrics & systems pharmacology · 2020Article
- Article
- Physiologically-based pharmacokinetic modeling of renally excreted antiretroviral drugs in pregnant women.British journal of clinical pharmacology · 2015Article
- 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
- The role of drug transporters in the kidney: lessons from tenofovir.Frontiers in pharmacology · 2014Review
- Pharmacology of HIV integrase inhibitors.Current opinion in HIV and AIDS · 2012Review
- Population pharmacokinetic analysis and pharmacogenetics of raltegravir in HIV-positive and healthy individuals.Antimicrobial agents and chemotherapy · 2012Article
- Acceptable plasma concentrations of raltegravir and etravirine when administered by gastrostomy tube in a patient with advanced multidrug-resistant human immunodeficiency virus infection.Pharmacotherapy · 2012Article
- Raltegravir is a substrate for SLC22A6: a putative mechanism for the interaction between raltegravir and tenofovir.Antimicrobial agents and chemotherapy · 2011Article
- Role of raltegravir in the management of HIV-1 infection.HIV/AIDS (Auckland, N.Z.) · 2011Article
- Raltegravir: The evidence of its therapeutic value in HIV-1 infection.Core evidence · 2010Article
- Drug-drug interactions with raltegravir.European journal of medical research · 2009Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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). This article reports the results of an open-label, sequential, three-period study of healthy subjects. Period 1 involved raltegravir at 400 mg twice daily for 4 days, period 2 involved tenofovir disoproxil fumarate (TDF) at 300 mg once daily for 7 days, and period 3 involved raltegravir at 400 mg twice daily plus TDF at 300 mg once daily for 4 days. Pharmacokinetic profiles were also determined in HIV-1-infected patients dosed with raltegravir monotherapy versus raltegravir in combination with TDF and lamivudine. There was no clinically significant effect of TDF on raltegravir. The raltegravir area under the concentration time curve from 0 to 12 h (AUC(0-12)) and peak plasma drug concentration (C(max)) were modestly increased in healthy subjects (geometric mean ratios [GMRs], 1.49 and 1.64, respectively). There was no substantial effect of TDF on raltegravir concentration at 12 h postdose (C(12)) in healthy subjects (GMR [TDF plus raltegravir-raltegravir alone], 1.03; 90% confidence interval [CI], 0.73 to 1.45), while a modest increase (GMR, 1.42; 90% CI, 0.89 to 2.28) was seen in HIV-1-infected patients. Raltegravir had no substantial effect on tenofovir pharmacokinetics: C(24), AUC, and C(max) GMRs were 0.87, 0.90, and 0.77, respectively. Coadministration of raltegravir and TDF does not change the pharmacokinetics of either drug to a clinically meaningful degree. Raltegravir and TDF may be coadministered without dose adjustments.
Indexed as
Identifiers
What OpenQuestion holds
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.