Trial reportJournal of acquired immune deficiency syndromes (1999)2010
Contraceptive efficacy of oral and transdermal hormones when co-administered with protease inhibitors in HIV-1-infected women: pharmacokinetic results of ACTG trial A5188.
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. It is linked to trial NCT00125983 (A Phase II Pharmacokinetic Study of the Transdermal Contraceptive System and Oral Contraceptive in HIV-1 Infected Women on Lopinavir/Ritonavir), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.
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 Phase II Pharmacokinetic Study of the Transdermal Contraceptive System and Oral Contraceptive in HIV-1 Infected Women on Lopinavir/Ritonavir
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 115 citations in OpenAlex.
- Drug interactions between hormonal contraceptives and antiretrovirals.AIDS (London, England) · 2017Pooled it
- Effects of ritonavir-boosted protease inhibitors on combined oral contraceptive pharmacokinetics and pharmacodynamics in HIV-positive women.Contraception · 2019Trial
- Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study.The lancet. HIV · 2019Trial
- 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
- Contraception in Medically Complex Adolescents and Young Adults.Open access journal of contraception · 2024Article
- Pharmacokinetics of levonorgestrel and etonogestrel contraceptive implants over 48 weeks with rilpivirine- or darunavir-based antiretroviral therapy.The Journal of antimicrobial chemotherapy · 2022Article
- Society of Family Planning Clinical Recommendations: Contraceptive Care in the Context of Pandemic Response.Contraception · 2022Article
- Interactions between Hormonal Contraception and Anti-Retroviral Therapy: An Updated Review.Current obstetrics and gynecology reports · 2020Article
- Potential risk of drug-drug interactions with hormonal contraceptives and antiretrovirals: prevalence in women living with HIV.Drugs in context · 2020Article
- "I felt like a TRIO champion": end-user perspectives on their role as co-designers of multi-purpose technologies.Gates open research · 2020Article
- 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
- Contraceptive challenges in adolescents living with or at risk of HIV.Journal of virus eradication · 2016Article
- Transgender populations and HIV: unique risks, challenges and opportunities.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
- Care of the HIV-infected pregnant woman in the developed world.Obstetric medicine · 2015Review
- Hormonal contraceptive use in HIV-infected women using antiretroviral therapy: A Systematic review.Open access journal of contraception · 2015Article
- HIV protease inhibitor use during pregnancy is associated with decreased progesterone levels, suggesting a potential mechanism contributing to fetal growth restriction.The Journal of infectious diseases · 2015Article
- Pharmacokinetic and pharmacodynamic drug interactions between antiretrovirals and oral contraceptives.Clinical pharmacokinetics · 2015Review
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 at 7 institutions in 1 country.
Funding
Abstract
backgroundPharmacokinetic (PK) interactions between lopinavir/ritonavir (LPV/r) and transdermally delivered ethinyl estradiol (EE) and norelgestromin (NGMN) are unknown.
methodsUsing a standard noncompartmental PK analysis, we compared EE area under the time-concentration curve (AUC) and NGMN AUC during transdermal contraceptive patch administration in HIV-1-infected women on stable LPV/r to a control group of women not on highly active antiretroviral therapy (HAART). In addition, EE AUC after a single dose of a combination oral contraceptive pill including EE and norethindrone was measured before patch placement and was compared with patch EE AUC in both groups. Contraceptive effects on LPV/r PKs were estimated by measuring LPV/r AUC at baseline and during week 3 of patch administration.
resultsEight women on LPV/r, and 24 women in the control group were enrolled. Patch EE median AUC0-168 h was 45% lower at 6010.36 pg·h·mL in those on LPV/r versus 10911.42 pg·h·mL in those on no HAART (P = 0.064). Pill EE median AUC0-48 hours was similarly 55% lower at 344.67 pg·h·mL in those on LPV/r versus 765.38 pg·h·mL in those on no HAART (P = 0.003). Patch NGMN AUC0-168 h however, was 138.39 ng·h·mL, 83% higher in the LPV/r group compared with the control AUC of 75.63 ng·h·mL (P = 0.036). After 3 weeks on the patch, LPV AUC0-8 h decreased by 19%, (P = 0.156).
conclusionsAlthough PKs of contraceptive EE and NGMN are significantly altered with LPV/r, the contraceptive efficacy of the patch is likely to be maintained. Larger studies are indicated to fully assess contraceptive efficacy versus risks of the transdermal contraceptive patch when co-administered with protease inhibitors.
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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.