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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 is a Phase 1 study that has completed, run by Ian McGowan. The registered enrollment target is 13 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01575405
The ClinicalTrials.gov registry entry for NCT01575405 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ian McGowan, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rectal formulation (RF) of tenofovir 1% gel is the first listed.
NCT01575405 reports 0 study locations.
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.
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