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NCT01906255 · ClinicalTrials.gov registry record
Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)
A clinical trial, sponsored by Gilead Sciences.
- Completed
- Registry status
- 10,577
- Enrollment target
NCT01906255 is a clinical trial that has completed, run by Gilead Sciences. The registered enrollment target is 10,577 participants.
The verdict
NCT01906255 has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- 10,577 participants
- Enrollment target
Study Summary
This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring. In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and HIV-1 infection status. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol. Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,577 participants |
| Start Date | 2013-10-07 |
| Est. Completion | 2021-04-27 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01906255
The ClinicalTrials.gov registry entry for NCT01906255 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10,577 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01906255 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01906255 about?
NCT01906255 is a clinical study titled "Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)". This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in t...
What is the current status of trial NCT01906255?
This trial is currently completed. The enrollment target is 10,577 participants. The study started on 2013-10-07. Estimated completion is 2021-04-27.
Who is sponsoring clinical trial NCT01906255?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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