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NCT01575405 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare Three Different Formulations of Tenofovir 1% Gel When Administered Rectally
A Phase 1 study, sponsored by Ian McGowan.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01575405: Completed Phase 1 study, sponsored by Ian McGowan.
NCT01575405 is a Phase 1 study that has completed, run by Ian McGowan. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01575405, a Phase 1 study, has completed, sponsored by Ian McGowan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a double-blinded, randomized, safety, acceptability, pharmacokinetic, and ex vivo efficacy study of three rectally-applied tenofovir-based microbicide formulations. Approximately 18 total evaluable HIV-negative men and women (\~9 per site) will be enrolled across two study sites: University of California at Los Angeles (UCLA) and Magee-Womens Research Institute (MWRI) at University of Pittsburgh. Each participant will experience seven rectal exposures to the rectal-specific formulation (RF) and seven rectal exposures to the reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel, but only one exposure to the vaginal formulation (VF), which will be coupled with six preceding exposures to the Universal HEC Placebo Gel to balance out the VF study stage. Participant accrual will take approximately 6 months and each participant will be on study for approximately 3 months. The total duration of the study will be approximately 1 year. The primary objectives of the study are safety, acceptability, and pharmacokinetics, specifically: * To evaluate the safety of each tenofovir-based microbicide gel formulation when applied rectally * To evaluate the acceptability of each tenofovir-based microbicide gel formulation when applied rectally * To compare systemic and compartment pharmacokinetics among the three tenofovir-based microbicide gel formulations when applied rectally Secondary objective of the study is to evaluate the mucosal immunotoxicity of each tenofovir-based microbicide gel formulation when applied rectally. And the exploratory objective of the study is to assess the preliminary (ex vivo) efficacy of each tenofovir-based microbicide gel formulation using biopsy explants after each product is applied rectally.
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 Addenda 1 and 3 (Female Genital and Rectal Grading Tables for Use in Microbicide Studies) will be used to assess safety.
Interventions
- DRUG Rectal formulation (RF) of tenofovir 1% gel
- DRUG Vaginal formulations (original VF and reduced vaginal glycerin formulation RGVF) of tenofovir 1% gel
- DRUG Universal HEC Placebo Gel Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01575405 record still lists
NCT01575405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Rectal formulation (RF) of tenofovir 1% gel is the first listed.
NCT01575405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01575405 about?
NCT01575405 is a clinical study titled "A Study to Compare Three Different Formulations of Tenofovir 1% Gel When Administered Rectally". This is a double-blinded, randomized, safety, acceptability, pharmacokinetic, and ex vivo efficacy study of three rectally-applied tenofovir-based microbicide formulations. Approximately 18 total evaluable HIV-negative men and women (\~9 per site) will be enrolled across two study sites: University ...
What is the current status of trial NCT01575405?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2013-03. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01575405?
The interventions under investigation include: Rectal formulation (RF) of tenofovir 1% gel (DRUG), Vaginal formulations (original VF and reduced vaginal glycerin formulation RGVF) of tenofovir 1% gel (DRUG), Universal HEC Placebo Gel Formulation (DRUG).
Who is sponsoring clinical trial NCT01575405?
This trial is sponsored by Ian McGowan, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01575405's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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