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Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

Gilead Sciences logo

Gilead Sciences

Status

Completed

Conditions

HIV

Study type

Observational

Funder types

Industry

Identifiers

NCT01906255
EUPAS24332 (Registry Identifier)
GS-US-276-0104

Details and patient eligibility

About

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.

Enrollment

10,577 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants in an FTC/TDF for PrEP observational or clinical study
  • HIV-1 negative individual at the time of enrollment in a demonstration project or clinical study
  • Participants with at least one measurement of tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) or tenofovir (TFV) in plasma

Exclusion criteria

  • This is an observational study and will collect HIV-1 infection and resistance information along with renal or skeletal adverse events without intervention.

Trial design

10,577 participants in 1 patient group

FTC/TDF for PrEP
Description:
HIV-1 negative adults (any sex/gender, including transgender, pregnancy) who are participating in observational or clinical studies on FTC/TDF for PrEP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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