ArticleThe Journal of infectious diseases2025
Anal Sex and Tenofovir Douche Sequence Impacts Colorectal Distribution of HIV Surrogate and Douche: DREAM-02.
Article in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04195776 (A Phase 1 Open Label Study Evaluating the Distribution of a Tenofovir Douche in Combination With Tap Water Douching and Simulated Receptive Anal Intercourse), which is not on this map. Not yet cited in PubMed.
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.
A Phase 1 Open Label Study Evaluating the Distribution of a Tenofovir Douche in Combination With Tap Water Douching and Simulated Receptive Anal Intercourse (DREAM-02)
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundMen who have sex with men are at high risk of human immunodeficiency virus (HIV) acquisition through unprotected receptive anal intercourse (RAI). Behaviorally congruent HIV preexposure prophylaxis (PrEP) has long been advocated by individuals who find adherence challenging or prefer minimizing systemic drug concentrations. We developed an event-driven, behaviorally congruent rectal tenofovir douche as a PrEP option for RAI and demonstrated product safety/acceptability in a previous clinical study. Here, our goal was to compare colorectal distribution of an HIV surrogate and tenofovir douche when the tenofovir douche preceded or followed simulated RAI (sRAI).
methodsFive participants completed 2 paired study visits. At visit one, participants received an 111indium-diethylenetriaminepentaacetic acid-labelled tenofovir douche prior to sRAI using 99mTc-sulfur colloid in autologous semen as HIV surrogate. At visit two, the radiolabeled tenofovir douche was administered following radiolabeled sRAI. Colorectal distribution of both douche and HIV surrogate radioisotopes were assessed using single-photon emission computed tomography/transmission computed tomography. Systemic permeability was assessed by plasma TFV concentrations.
resultsColorectal distribution of the douche was not different between sequences. Conversely, the majority of HIV surrogate was within the rectosigmoid when the douche was administered prior to sRAI, but the distribution extended into descending colon when the douche was administered following sRAI. Regardless of sequence, an early plasma TFV peak 20 minutes after dosing was observed.
conclusionsDouching following RAI may increase HIV distribution in the colon with uncertain impact on HIV acquisition risk. The early plasma TFV suggests even more rapid time to protection than reported in prior studies. CLINICAL TRIALS REGISTRATION: NCT04195776.
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.