Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT01575418
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2012-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations
Sponsor:
Ian McGowan
Organization:
Study Overview
Official Title:
An Exploratory, Double-Blinded, Randomized, Pharmacokinetic and Safety Study of Three Rectally-Applied Tenofovir 1% Microbicide Gel Formulations
Status:
COMPLETED
Status Verified Date:
2014-05
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, 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.
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.
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 |