Trial reportJournal of the International AIDS Society2025
Evaluation of long-acting cabotegravir safety and pharmacokinetics in pregnant women in eastern and southern Africa: a secondary analysis of HPTN 084.
Trial report in Journal of the International AIDS Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- Vaginal Microbiota and Cytokines Among Pregnant and Breastfeeding Women in Clinical Trials of the Dapivirine Vaginal Ring and Oral Tenofovir Disoproxil Fumarate/Emtricitabine.Open forum infectious diseases · 2026Trial
- Exploring Preferences for Long-Acting Injectable PrEP Among Postpartum Women in South Africa Using the Consolidated Framework for Implementation Research: The Siphila Sonke Study.AIDS and behavior · 2026Article
- Effectiveness, Sex Differences, and Patient Experience in Real-World Use of Long-Acting Cabotegravir and Rilpivirine: Results from a Prospective Study.Infectious diseases and therapy · 2026Article
- Long-Acting Injectable Antiretroviral Therapies for HIV Treatment and Prevention: Clinical Pharmacology, Recent Advances and Future Opportunities.Journal of clinical pharmacology · 2026Review
- Special Issue: New Horizons in HIV and Reproductive Health Research: HIV Acquisition and Reproductive Health in Key Populations.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Long-Acting HIV Pre-exposure Prophylaxis Preferences Through Pregnancy and the Postpartum Period Among Women in Kenya: A Latent Transition Analysis.AIDS and behavior · 2026Article
- Exploring the pharmacokinetic mechanisms that affect bictegravir exposure during pregnancy.The Journal of antimicrobial chemotherapy · 2026Article
- A rapid qualitative analysis of health care worker and community focus groups on determinants and implementation strategies for long-acting PrEP in antenatal and postpartum settings in Kenya.Discover health systems · 2026Article
- Article
- Fetal Defects in Mice Treated With Integrase Strand Transfer Inhibitors: Comparison of Dolutegravir, Raltegravir, Bictegravir, and Cabotegravir.The Journal of infectious diseases · 2025Article
- Multisector global collaboration to advance the inclusion of pregnant and lactating people in HIV prevention research.AIDS (London, England) · 2025Article
- Third-Trimester HIV Viremia Treated With Long-Acting Cabotegravir and Rilpivirine: A Case Report.Open forum infectious diseases · 2025Article
- Article
- Postpartum women's prospective acceptability of long-acting HIV prevention approaches in Kenya: a qualitative study.BMC health services research · 2025Article
- Long-Acting Injectable Antiretroviral Drugs for Pregnant and Breastfeeding Women: Current Advances, Challenges, and Future Directions.Current HIV/AIDS reports · 2025Review
- Long-acting pre-exposure prophylaxis preferences among pregnant and postpartum women in Kenya: results from a discrete choice experiment.AJOG global reports · 2025Article
- Southern African HIV Clinicians Society guideline on pre-exposure prophylaxis to prevent HIV.Southern African journal of HIV medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
Abstract
introductionLong-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis significantly reduced HIV acquisition in HPTN 084. We report on the safety and CAB-LA pharmacokinetics in pregnant women during the blinded period of HPTN 084.
methodsParticipants were randomized 1:1 to either active cabotegravir (CAB) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) placebo or active TDF/FTC plus CAB placebo. Pregnancy testing was performed at each visit; participants with a positive test had study product withheld and were offered open-label TDF/FTC. Pregnancies were confirmed on two tests at least 4 weeks apart. All participants with a positive pregnancy test prior to November 5, 2020 are included in this analysis. Pregnancy incidence, maternal adverse event (AE) incidence, pregnancy outcomes (including composite outcome of spontaneous abortion <20 weeks, intrauterine foetal death or stillbirth ≥20 weeks, premature birth <37 weeks, or small for gestational age) were assessed. The apparent terminal phase half-life (t
conclusionsCAB-LA concentrations post-cessation of injections were generally well tolerated in pregnant women. The t
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.