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NCT02985996 · ClinicalTrials.gov registry record · Phase 1
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02985996: Completed Phase 1 study, sponsored by Emory University.
NCT02985996 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02985996, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
Primary Outcome
Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Interventions
- DRUG Truvada
- DRUG Genvoya
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2017-11-29 |
| Phase | Phase 1 |
What the finished NCT02985996 record still lists
NCT02985996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Truvada is the first listed.
NCT02985996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02985996 about?
NCT02985996 is a clinical study titled "Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities". The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 ...
What is the current status of trial NCT02985996?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2017-02-06. Estimated completion is 2017-11-29.
What interventions are being tested in trial NCT02985996?
The interventions under investigation include: Truvada (DRUG), Genvoya (DRUG).
Who is sponsoring clinical trial NCT02985996?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02985996's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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