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NCT07181486 · ClinicalTrials.gov registry record · Phase 1
Safety Study of MucoCept-CVN
A Phase 1 study of HIV-1-infection, sponsored by Craig Cohen, MD, MPH.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07181486: Recruiting Phase 1 study of HIV-1-infection, sponsored by Craig Cohen, MD, MPH.
NCT07181486 is a Phase 1 study of HIV-1-infection that is actively recruiting participants, run by Craig Cohen, MD, MPH. The registered enrollment target is 12 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07181486, a Phase 1 study of HIV-1-infection, is actively recruiting participants, sponsored by Craig Cohen, MD, MPH.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV. The goal of this first-in-human Phase 1 dose-ranging, randomized, placebo-controlled study of MucoCept-CVN is to collect data on safety, colonization, changes to the vaginal microbiota and clearance of the strain with antibiotics. Twelve healthy women will be enrolled and take either one or three doses of MucoCept-CVN or placebo, and a week later will receive antibiotics to clear the Lactobacillus strain. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, long-acting, female-initiated prevention product for women that promotes vaginal health and provides protection from HIV.
Primary Outcome
Proportion of participants with serious adverse events, any genital AEs and Grade 2 or above systemic AEs.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Live Biotherapeutic Product L. jensenii 1153-1666
Study Locations (1)
California
- UCSF Zuckerberg San Francisco General Hospital - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-10-06 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 1 |
What NCT07181486 shows while recruiting
NCT07181486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (97% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07181486 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07181486 about?
NCT07181486 is a clinical study titled "Safety Study of MucoCept-CVN". MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug. If research shows that MucoCept-CVN is safe and effective, it could become a self-renewing, female-initiated prevention pr...
What is the current status of trial NCT07181486?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-10-06. Estimated completion is 2027-10-31.
What conditions does trial NCT07181486 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT07181486?
The interventions under investigation include: Placebo (DRUG), Live Biotherapeutic Product L. jensenii 1153-1666 (DRUG).
Who is sponsoring clinical trial NCT07181486?
This trial is sponsored by Craig Cohen, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07181486 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07181486's enrollment target sits among peer trials
12 68th of 71 higher than 3 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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