Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT01575405
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2012-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare Three Different Formulations of Tenofovir 1% Gel When Administered Rectally
Sponsor:
Ian McGowan
Organization:
Study Overview
Official Title:
A Randomized, Double Blind Phase 1 Safety, Acceptability, and Pharmacokinetic Study Comparing Three Formulations of Tenofovir 1% Gel Administered Rectally to HIV-1 Seronegative Adults
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5U19AI082637 | NIH | None | https://reporter.nih.gov/quic… | View |