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NCT00592124 · ClinicalTrials.gov registry record · Phase 2
Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 7
- Study locations
NCT00592124: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00592124 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 168 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (62% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00592124, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 7
- Study locations
Study Summary
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adherence and acceptability to and blood levels of three daily regimens of tenofovir in both oral and gel form.
Primary Outcome
Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.
Conditions Studied
Interventions
- DRUG Tenofovir disoproxil fumarate
- DRUG Tenofovir gel
Study Locations (7)
KwaZulu-Natal
- Botha's Hill CRS - Durban
- Umkomaas CRS - Durban
Alabama
- Alabama Microbicide CRS - Birmingham
New York
- Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS) - The Bronx
Ohio
- Case CRS - Cleveland
Pennsylvania
- Pitt CRS - Pittsburgh
Other
- Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS - Kampala
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
What the finished NCT00592124 record still lists
NCT00592124 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (62% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Tenofovir disoproxil fumarate is the first listed.
NCT00592124 lists 7 locations in 6 states (KwaZulu-Natal, Alabama, New York).
Frequently Asked Questions
What is clinical trial NCT00592124 about?
NCT00592124 is a clinical study titled "Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women". A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adher...
What is the current status of trial NCT00592124?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2008-06. Estimated completion is 2010-07.
What conditions does trial NCT00592124 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00592124?
The interventions under investigation include: Tenofovir disoproxil fumarate (DRUG), Tenofovir gel (DRUG).
Who is sponsoring clinical trial NCT00592124?
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 NCT00592124 being conducted?
This trial has 7 study locations across Alabama, New York, Ohio, Pennsylvania, KwaZulu-Natal. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00592124's enrollment target sits among peer trials
168 196th of 542 higher than 344 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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