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NCT01327651 · ClinicalTrials.gov registry record · Phase 2

The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)

A Phase 2 study, sponsored by HIV Prevention Trials Network.

Completed
Registry status
Phase 2
Development phase
622
Enrollment target

NCT01327651: Completed Phase 2 study, sponsored by HIV Prevention Trials Network.

NCT01327651 is a Phase 2 study that has completed, run by HIV Prevention Trials Network. The registered enrollment target is 622 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (368% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01327651, a Phase 2 study, has completed, sponsored by HIV Prevention Trials Network.

COMPLETED
Registry status
Phase 2
Development phase
622 participants
Enrollment target

Study Summary

Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will examine the feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will be compared: daily, time-based, and event-based.

Primary Outcome

Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as "covered" if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if parti

Interventions

  • DRUG Daily dosing
  • DRUG Time-driven dosing
  • DRUG Event-driven dosing

Trial Details

FieldValue
Enrollment Target 622 participants
Start Date 2011-08
Est. Completion 2014-12
Phase Phase 2
HIV Prevention Trials Network

10 total trials

What the finished NCT01327651 record still lists

NCT01327651 is an interventional study that assigns participants to a tested intervention. The registered 622 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 (368% higher).

The record links to 0 conditions, and to 3 interventions - of which Daily dosing is the first listed.

NCT01327651 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01327651 about?

NCT01327651 is a clinical study titled "The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)". Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will examine the feasibility of different methods of dosing for a PrEP regimen. Three methods of delivery will be compared: daily, time-based...

What is the current status of trial NCT01327651?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 622 participants. The study started on 2011-08. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01327651?

The interventions under investigation include: Daily dosing (DRUG), Time-driven dosing (DRUG), Event-driven dosing (DRUG).

Who is sponsoring clinical trial NCT01327651?

This trial is sponsored by HIV Prevention Trials Network, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01327651's enrollment target sits among peer trials

622 52nd of 2000 higher than 1,949 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

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Source: ClinicalTrials.gov NCT01327651, the US trial registry maintained by the National Library of Medicine. NCT01327651 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.