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

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Connie Celum, University of Washington
ClinicalTrials.gov Identifier:
NCT00557245
First received: November 8, 2007
Last updated: November 15, 2013
Last verified: November 2013

November 8, 2007
November 15, 2013
May 2008
October 2013   (final data collection date for primary outcome measure)
  • Efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexual HIV-1 discordant couples. [ Time Frame: Up to 24 months-36 months ] [ Designated as safety issue: No ]
  • Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF to those randomized to placebo. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: Yes ]
  • Efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexual HIV-1 discordant couples. [ Time Frame: Up to 24 months-36 months ]
  • Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF to those randomized to placebo. [ Time Frame: Up to 24-36 months. ]
Complete list of historical versions of study NCT00557245 on ClinicalTrials.gov Archive Site
  • Reported risk behaviours, STI prevalence, pill counts and reported adherence. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: No ]
  • HIV-1 drug resistance, plasma HIV-1 RNA levels and CD4 T cell counts among HIV-1 seroconverters. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: Yes ]
  • Congenital abnormalities, growth and development among infants born to female participants taking study drug. [ Time Frame: Up to 24-36 months ] [ Designated as safety issue: Yes ]
  • Reported risk behaviours, STI prevalence, pill counts and reported adherence. [ Time Frame: Up to 24-36 months ]
  • HIV-1 drug resistance, plasma HIV-1 RNA levels and CD4 T cell counts among HIV-1 seroconverters, [ Time Frame: Up to 24-36 months ]
  • Congenital abnormalities, growth and development among infants born to female participants taking study drug. [ Time Frame: Up to 24-36 months ]
Not Provided
Not Provided
 
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

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.

HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high-risk for HIV-acquisition. The majority of HIV-1 transmissions to adults in Africa occur within stable, HIV-1 discordant couples.

Pre-exposure chemoprophylaxis, in which an HIV-1 uninfected individual at high risk for contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been proposed as a potential HIV-1 prevention strategy.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV-1 Infections
  • HIV Infections
  • Drug: Tenofovir Disoproxil Fumarate (TDF)
    TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
    Other Name: Viread + Placebo Truvada
  • Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
    FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
    Other Name: Truvada + Placebo Viread
  • Drug: Placebo
    Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
    Other Name: Placebo + Placebo
  • Active Comparator: I
    Intervention: Drug: Tenofovir Disoproxil Fumarate (TDF)
  • Active Comparator: 2
    Intervention: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
  • Placebo Comparator: 3
    Placebo TDF + Placebo FTC/TDF orally, once daily.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4758
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria for HIV-1 uninfected partner:

  • Partner within an HIV-1 discordant heterosexual relationship
  • One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
  • Plan to remain in the relationship for the duration of the study period
  • Adequate renal, hepatic & hematologic function
  • Negative Hepatitis B surface antigen test
  • Willing and able to provide written informed consent & locator information

Exclusion Criteria for HIV-1 uninfected partner:

  • Current pregnancy, or planning to become pregnant during the study period
  • Currently breastfeeding
  • Concurrent enrollment in another HIV-1 vaccine or prevention trial
  • Receiving ongoing antiretroviral therapy
  • Repeated positive urine dipstick tests for glycosuria or proteinuria
  • Active and serious infections
  • History of pathological bone fractures not related to trauma

Inclusion Criteria for HIV-1 infected partner:

  • Partner within an HIV-1 discordant heterosexual relationship
  • One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant
  • HIV-1 infected based on positive EIA
  • No history of any clinical AIDS-defining diagnoses
  • Plan to remain in the relationship for the duration of the study period
  • Willing and able to provide written informed consent & locator information

Exclusion Criteria for HIV-1 infected partner:

  • Current use of antiretroviral therapy
  • Concurrent enrollment in another HIV-1 treatment trial
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya,   Uganda
 
NCT00557245
32528-A, IND 75,365;, 07-7454-A-01
Yes
Connie Celum, University of Washington
University of Washington
Bill and Melinda Gates Foundation
Study Chair: Connie Celum,, MD, MPH University of Washington
Study Director: Jared Baeten, MD, PhD University of Washington
University of Washington
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP