Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Tenofovir, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For eGFR, participants may enroll in the study with an eGFR value consistent with a grade 2 adverse event; thus, an exception will be made for eGFR, which will be considered a safety outcome if it worsens to a grade 3 or higher.
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 |
What the registry record for NCT06560684 still lists
NCT06560684 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
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 lists 8 locations in 8 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06560684's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI