Trial reportThe Annals of pharmacotherapy2015
Dolutegravir Has No Effect on the Pharmacokinetics of Oral Contraceptives With Norgestimate and Ethinyl Estradiol.
Trial report in The Annals of pharmacotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Drug interactions between hormonal contraceptives and antiretrovirals.AIDS (London, England) · 2017Pooled it
- Effect of Cladribine Tablets on the Pharmacokinetics of a Combined Oral Contraceptive in Pre-Menopausal Women With Relapsing Multiple Sclerosis.Clinical and translational science · 2025Trial
- TLD-Based Antiretroviral Therapy Compromises Ovarian Function and Reserve: Evidence from Experimental and Clinical Studies.Reproductive sciences (Thousand Oaks, Calif.) · 2026Article
- Update on HIV prevention and management in pregnancy Number 10 - 2025.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025Article
- Drug-Drug Interactions Between HIV Antivirals and Concomitant Drugs in HIV Patients: What We Know and What We Need to Know.Pharmaceutics · 2024Review
- U.S. Medical Eligibility Criteria for Contraceptive Use, 2024.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2024Article
- Oestradiol concentrations in trans women with HIV suppressed on unboosted integrase inhibitor regimens versus trans women without HIV taking oral oestradiol: a pilot study.The Journal of antimicrobial chemotherapy · 2023Article
- Measuring the impact of COVID-19 social distancing measures on sexual health behaviours and access to HIV and sexual and reproductive health services for people living with HIV in Botswana.Frontiers in global women's health · 2023Article
- South African healthcare workers' knowledge of dolutegravir's drug-drug interactions in the first year of its rollout: a cross-sectional online survey.Journal of the International AIDS Society · 2022Article
- In vitro assessment of the potential for dolutegravir to affect hepatic clearance of levonorgestrel.HIV medicine · 2021Article
- Pregnancies among women living with HIV using contraceptives and antiretroviral therapy in western Kenya: a retrospective, cohort study.BMC medicine · 2021Article
- Etonogestrel concentrations among contraceptive implant users in Botswana using and not using dolutegravir-based antiretroviral therapy.Contraception · 2020Article
- A pharmacokinetic and pharmacogenetic evaluation of contraceptive implants and antiretroviral therapy among women in Kenya and Uganda.AIDS (London, England) · 2019Article
- Contraceptive implant failures among women using antiretroviral therapy in western Kenya: a retrospective cohort study.Gates open research · 2019Article
- Current and future contraceptive options for women living with HIV.Expert opinion on pharmacotherapy · 2018Review
- Drug-Drug Interactions, Effectiveness, and Safety of Hormonal Contraceptives in Women Living with HIV.Drug safety · 2016Review
- Transgender populations and HIV: unique risks, challenges and opportunities.Journal of virus eradication · 2016Article
- Contraceptive challenges in adolescents living with or at risk of HIV.Journal of virus eradication · 2016Article
- Transgender women, hormonal therapy and HIV treatment: a comprehensive review of the literature and recommendations for best practices.Journal of the International AIDS Society · 2016Review
- Reduced Effectiveness of Contraceptive Implants for Women Taking the Antiretroviral Efavirenz (EFV): Still Good Enough and for How Long?Global health, science and practice · 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
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDolutegravir (DTG; Tivicay; ViiV Healthcare, Research Triangle Park, NC) is an HIV-1-unboosted integrase inhibitor with no cytochrome P450 or uridine 5'diphosphate-glucuronosyltransferase inhibition or induction. As DTG is administered to HIV-1-infected women receiving oral contraceptives, assessing the potential for drug interactions was warranted.
objectiveTo determine the impact of DTG on the pharmacokinetics (PK) and pharmacodynamics (PD) of a common oral contraceptive, norgestimate/ethinyl estradiol (NGM/EE; Ortho-Cyclen; Ortho-McNeil-Janssen Pharmaceuticals, Inc, Raritan, NJ).
methodsThis randomized, 2-period, double-blind, placebo-controlled study was conducted within 1 menstrual cycle at 1 clinical center in the United States; 16 women were enrolled. Participants received NGM 0.25 mg/EE 0.035 mg throughout the study. During days 1 to 10, they were randomized to receive twice-daily DTG 50 mg or matching placebo with food and switched to the other treatment during days 12 to 21.
resultsRatios of area under the concentration-time curve from time 0 until end of the dosage interval (AUC0-τ), maximum plasma concentration, and concentration at the end of the dosage interval of norelgestromin with DTG treatment to the same PK parameters with placebo treatment were 0.975, 0.890, and 0.932, respectively; for EE, ratios were 1.03, 0.99, and 1.02, respectively. No significant differences in luteinizing hormone, follicle-stimulating hormone, and progesterone were detected on days 1, 10, 11, 21, and 22. DTG steady-state AUC0-τ was similar to historical data. No severe or grade 3/4 adverse events occurred.
conclusionsDTG had no effect on NGM/EE PK or PD. NGM/EE can be administered with DTG without dose adjustment.
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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.