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Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

NCT00557245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4758

Last updated 2019-04-19

Study results available
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Summary

Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.

Conditions

  • HIV-1 Infections
  • HIV Infections

Interventions

DRUG

Tenofovir Disoproxil Fumarate (TDF)

TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.

DRUG

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily

DRUG

Placebo

Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.

Sponsors & Collaborators

Principal Investigators

  • Connie Celum,, MD, MPH · University of Washington

  • Jared Baeten, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Kenya
  • Uganda

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557245 on ClinicalTrials.gov