Trial reportOpen forum infectious diseases2026
Vaginal Microbiota and Cytokines Among Pregnant and Breastfeeding Women in Clinical Trials of the Dapivirine Vaginal Ring and Oral Tenofovir Disoproxil Fumarate/Emtricitabine.
Trial report in Open forum infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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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.
Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy
Phase 3B, Randomized, Open-Label, Safety, and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Vaginal dysbiosis is associated with HIV acquisition and preterm delivery. Our objective was to evaluate prevalent vaginal infections, and changes in microbiota and cytokines among pregnant and breastfeeding women from 4 African countries using dapivirine vaginal ring (DVR) or oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 2 parallel nonoverlapping trials. Methods: MTN-042 (NCT03965923) was a randomized trial evaluating daily TDF/FTC or monthly DVR during pregnancy (n = 558), and MTN-043 (NCT04140266) was a randomized study evaluating TDF/FTC or DVR during breastfeeding (n = 197). Women were evaluated for vaginal infections at enrollment and follow-up using Nugent score and BD Max™ Vaginal Panel. Microbiota was evaluated by quantitative PCR for 12 bacterial targets; 5 cytokines and RANTES were evaluated by MAGPIX. Rates of change in vaginal microbiota and cytokines and prevalence of vaginal infections were evaluated using generalized linear mixed models and Benjamini-Hochberg (BH)-adjusted Results: Vaginal infections, microbiota and cytokines did not differ between the 2 study arms at baseline. Conclusions: Vaginal infections, microbiota or cytokines/chemokines changes were similar in women using DVR or TDF/FTC. These data augment the robust safety profile for DVR to support its use during pregnancy and breastfeeding.
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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 Socratic graph.