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NCT06560684 · ClinicalTrials.gov registry record · Phase 2
Crossover Study OF On-demand Prep Formulations Comparing Rectal AND Oral Tenofovir
A Phase 2 study of Tenofovir, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 8
- Study locations
NCT06560684 is a Phase 2 study of Tenofovir that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 150 participants. The trial reports 8 study locations across 8 states.
The verdict
NCT06560684, a Phase 2 study of Tenofovir, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.
Conditions Studied
Interventions
- DRUG Oral F/TDF Pills
- DRUG TFV rectal douche
Study Locations (8)
Alabama
- Alabama CRS (Site ID# 31788) - Birmingham
California
- UCLA CARE Center CRS - Los Angeles
Georgia
- Hope Clinic CRS - Lawrenceville
Maryland
- Johns Hopkins University CRS - Baltimore
Massachusetts
- Fenway Health (FH) CRS - Boston
New York
- Weill Cornell Chelsea CRS - New York
North Carolina
- Chapel Hill CRS (3201) - Chapel Hill
Pennsylvania
- University of Pittsburgh CRS - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2026-05-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06560684
The ClinicalTrials.gov registry entry for NCT06560684 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tenofovir appearing as the primary indexed condition, and to 2 interventions - of which Oral F/TDF Pills is the first listed.
NCT06560684 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Alabama, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06560684 about?
NCT06560684 is a clinical study titled "Crossover Study OF On-demand Prep Formulations Comparing Rectal AND Oral Tenofovir". This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of sa...
What is the current status of trial NCT06560684?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-10-29. Estimated completion is 2026-05-15.
What conditions does trial NCT06560684 study?
This clinical trial studies the following conditions: Tenofovir.
What interventions are being tested in trial NCT06560684?
The interventions under investigation include: Oral F/TDF Pills (DRUG), TFV rectal douche (DRUG).
Who is sponsoring clinical trial NCT06560684?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06560684 being conducted?
This trial has 8 study locations across Alabama, California, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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