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NCT01813162 · ClinicalTrials.gov registry record · Phase 1
In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
A Phase 1 study of HIV Prevention, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
- 2
- Study locations
NCT01813162: Completed Phase 1 study of HIV Prevention, sponsored by CONRAD.
NCT01813162 is a Phase 1 study of HIV Prevention that has completed, run by CONRAD. The registered enrollment target is 101 participants, below the 379-participant average among 32 other HIV Prevention trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01813162, a Phase 1 study of HIV Prevention, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the study is determine if the local release characteristics and systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use
Primary Outcome
Vaginal product alone: Participant will use assigned product per dosing instructions (antifungal cream: 7 days; antimicrobial gel: 5 days; IVR: 21 days). In cream or gel cohorts, blood will be drawn 6 hrs after last use. In contraceptive ring cohort, blood will be drawn after 21 days of use at 0/4,6,10\&24 hrs. TFV gel alone: Participant will use TFV gel for 7 days, inserted 2X a day. In cream/gel cohorts blood will be drawn 4 hrs after last TFV gel use. In contraceptive ring cohort blood will
Conditions Studied
Interventions
- DRUG Tenofovir 1% gel
- DRUG Vaginal product
Study Locations (2)
California
- Dept of OBGYN and Reproductive Sciences, UCSF - San Francisco
New York
- Bronx-Lebanon Hospital Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01813162 record still lists
NCT01813162 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 32 other HIV Prevention trials with a reported enrollment target (73% lower).
The record links to 1 condition, with HIV Prevention appearing as the primary indexed condition, and to 2 interventions - of which Tenofovir 1% gel is the first listed.
NCT01813162 reports a single indexed study location in California, New York.
Frequently Asked Questions
What is clinical trial NCT01813162 about?
NCT01813162 is a clinical study titled "In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products". The purpose of the study is determine if the local release characteristics and systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use
What is the current status of trial NCT01813162?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2013-12. Estimated completion is 2014-12.
What conditions does trial NCT01813162 study?
This clinical trial studies the following conditions: HIV Prevention.
What interventions are being tested in trial NCT01813162?
The interventions under investigation include: Tenofovir 1% gel (DRUG), Vaginal product (DRUG).
Who is sponsoring clinical trial NCT01813162?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01813162 being conducted?
This trial has 2 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Prevention
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 NCT01813162's enrollment target sits among peer trials
101 17th of 32 higher than 16 of 32 other HIV Prevention trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Prevention 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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