Trial reportBritish journal of clinical pharmacology2011
Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572.
Trial report in British journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02542852 (A Pilot Phase II Study of a Nucleoside Sparing Regimen of Dolutegravir + Atazanavir/r in HIV-1 Infected Patients With Detectable Viremia), which is not on this map. Cited by 33 papers.
What it found
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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 Pilot Phase II Study of a Nucleoside Sparing Regimen of Dolutegravir + Atazanavir/r in HIV-1 Infected Patients With Detectable Viremia (DOLATAV Study)
Who cites it
33 citing papers in PubMed.
- Effect of fosamprenavir-ritonavir on the pharmacokinetics of dolutegravir in healthy subjects.Antimicrobial agents and chemotherapy · 2014Trial
- A nucleoside-sparing regimen of dolutegravir plus ritonavir-boosted atazanavir in HIV-1-infected patients with virological failure: the DOLATAV study.Drug design, development and therapyTrial
- Minor Contribution of UGT1A1 Inhibition to Atazanavir-Related Bilirubin Elevation Supported by Conservative PBPK Modeling and Clinical Data.Clinical pharmacology and therapeutics · 2026Article
- Dolutegravir concentrations in children receiving 3-month weekly isoniazid and rifapentine (3HP) for tuberculosis prevention.Microbiology spectrum · 2026Observational
- Inhibition of OATP1B1/3 Rather Than UGT1A1 May Be the Major Cause of the Bilirubin Elevation After Atazanavir Administration.Clinical pharmacology and therapeutics · 2025Article
- Drug-Drug Interactions Between HIV Antivirals and Concomitant Drugs in HIV Patients: What We Know and What We Need to Know.Pharmaceutics · 2024Review
- Pharmacokinetics and Safety of Twice-daily Ritonavir-boosted Atazanavir With Rifampicin.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Management of Drug Interactions with Inducers: Onset and Disappearance of Induction on Cytochrome P450 3A4 and Uridine Diphosphate Glucuronosyltransferase 1A1 Substrates.European journal of drug metabolism and pharmacokinetics · 2023Article
- Combined Oral Contraceptives As Victims of Drug Interactions.Drug metabolism and disposition: the biological fate of chemicals · 2023Review
- PBPK Modeling as a Tool for Predicting and Understanding Intestinal Metabolism of Uridine 5'-Diphospho-glucuronosyltransferase Substrates.Pharmaceutics · 2021Review
- Drug-drug interaction of atazanavir on UGT1A1-mediated glucuronidation of molidustat in human.Basic & clinical pharmacology & toxicology · 2021Article
- How Science Is Driving Regulatory Guidances.Methods in molecular biology (Clifton, N.J.) · 2021Article
- Is Dolutegravir Plus Atazanavir Overburdened With Concentration-Related Neurological Events Compared With Other Dual Regimens?Open forum infectious diseases · 2019Article
- Effect of Rifampin on the Single-Dose Pharmacokinetics of Oral Cabotegravir in Healthy Subjects.Antimicrobial agents and chemotherapy · 2017Article
- Drug-Drug Interaction between the Direct-Acting Antiviral Regimen of Ombitasvir-Paritaprevir-Ritonavir plus Dasabuvir and the HIV Antiretroviral Agent Dolutegravir or Abacavir plus Lamivudine.Antimicrobial agents and chemotherapy · 2016Article
- Effect of carbamazepine on dolutegravir pharmacokinetics and dosing recommendation.European journal of clinical pharmacology · 2016Article
- The role of dolutegravir in the management of HIV infection.Infection and drug resistance · 2015Review
- Clinical effectiveness of dolutegravir in the treatment of HIV/AIDS.Infection and drug resistance · 2015Review
- Dolutegravir - a review of the pharmacology, efficacy, and safety in the treatment of HIV.Drug design, development and therapy · 2015Review
- Pharmacokinetics of dolutegravir in a premature neonate after HIV treatment intensification during pregnancy.Antimicrobial agents and chemotherapy · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsS/GSK1349572 is an unboosted, once daily, next generation integrase inhibitor with potent activity, low pharmacokinetic (PK) variability and a novel resistance profile. As the primary route of metabolism is via glucuronidation, the effects of atazanavir (ATV, a UGT1A1 inhibitor) and atazanavir/ritonavir (ATV/RTV) on S/GSK1349572 PK were evaluated.
methodsA randomized, open label, two period, crossover study was conducted in healthy adult subjects. Twenty-four subjects received S/GSK1349572 30 mg every 24 h for 5 days. Subjects then were administered S/GSK1349572 30 mg every 24 h in combination with either ATV/RTV 300/100 mg every 24 h (n= 12) or ATV 400 mg every 24 h (n= 12) for 14 days. Serial PK samples and safety assessments were obtained throughout the study.
resultsThe combination of S/GSK1349572 with ATV/RTV or ATV was generally well tolerated. All adverse events were mild or moderate, and no subject withdrew because of an adverse event. The AE of highest frequency was ocular icterus, observed only during combination of S/GSK1349572 and ATV or ATV/RTV. Co-administration with ATV/RTV resulted in increased plasma S/GSK1349572 area under the concentration-time curve during a dosing interval (AUC(0,τ)), observed maximal concentration (C(max) ), and concentration at the end of dosing interval at steady state (C(τ) ) by 62%, 34% and 121%, respectively. Co-administration with ATV resulted in increased plasma S/GSK1349572 AUC(0,τ), C(max) , and C(τ) by 91%, 50% and 180%, respectively.
conclusionsCo-administration of ATV/RTV and ATV was generally well tolerated and produced a modest, non-clinically significant increase in S/GSK1349572 exposure. No dose adjustment for S/GSK1349572 is necessary when co-administered with ATV and ATV/RTV.
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