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NCT01575418 · ClinicalTrials.gov registry record · Phase 1
An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations
A Phase 1 study of HIV Prevention, sponsored by Ian McGowan.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01575418: Completed Phase 1 study of HIV Prevention, sponsored by Ian McGowan.
NCT01575418 is a Phase 1 study of HIV Prevention that has completed, run by Ian McGowan. The registered enrollment target is 9 participants, below the 382-participant average among 32 other HIV Prevention trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01575418, a Phase 1 study of HIV Prevention, has completed, sponsored by Ian McGowan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be enrolled. Each participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose.
Primary Outcome
Grade 2 or higher clinical and laboratory adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies) will be used to assess safety.
Conditions Studied
Interventions
- DRUG Rectal formulation (RF) of tenofovir 1% gel
- DRUG Vaginal formulation (VF) of tenofovir 1% gel
- DRUG Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel
- RADIATION Radiolabeling of study drugs and semen
Study Locations (1)
Maryland
- Johns Hopkins University, Division of Clinical Pharmacology, Drug Development Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01575418 record still lists
NCT01575418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 382-participant average among 32 other HIV Prevention trials with a reported enrollment target (98% lower).
The record links to 1 condition, with HIV Prevention appearing as the primary indexed condition, and to 4 interventions - of which Rectal formulation (RF) of tenofovir 1% gel is the first listed.
NCT01575418 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01575418 about?
NCT01575418 is a clinical study titled "An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations". This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be enrolled. Each participan...
What is the current status of trial NCT01575418?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-03. Estimated completion is 2013-11.
What conditions does trial NCT01575418 study?
This clinical trial studies the following conditions: HIV Prevention.
What interventions are being tested in trial NCT01575418?
The interventions under investigation include: Rectal formulation (RF) of tenofovir 1% gel (DRUG), Vaginal formulation (VF) of tenofovir 1% gel (DRUG), Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel (DRUG), Radiolabeling of study drugs and semen (RADIATION).
Who is sponsoring clinical trial NCT01575418?
This trial is sponsored by Ian McGowan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01575418 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01575418's enrollment target sits among peer trials
9 33rd of 32 the lowest 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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