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
  Purpose

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.


Condition Intervention Phase
HIV-1 Infections
HIV Infections
Drug: Tenofovir Disoproxil Fumarate (TDF)
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4758
Study Start Date: May 2008
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I Drug: Tenofovir Disoproxil Fumarate (TDF)
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Other Name: Viread + Placebo Truvada
Active Comparator: 2 Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Other Name: Truvada + Placebo Viread
Placebo Comparator: 3
Placebo TDF + Placebo FTC/TDF orally, once daily.
Drug: Placebo
Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Other Name: Placebo + Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557245

Locations
Kenya
Moi University - Indiana University
Eldoret, Kenya
CMR, Kemri-UCSF
Kisumu, Kenya
Kenyatta National Hospital/University of Nairobi
Nairobi, Kenya
Partners in Prevention - Thika
Thika, Kenya
Uganda
Kabwohe Clinical Research Center
Bushenyi, Uganda
Infectious Diseases Institute
Jinja, Uganda
Partners House-Infectious Disease Institute Ltd
Kampala, Uganda
The AIDS Support Organization (TASO)
Mbale, Uganda
The AIDS Support Organization - Tororo Field Station
Tororo, Uganda
Sponsors and Collaborators
University of Washington
Bill and Melinda Gates Foundation
Investigators
Study Chair: Connie Celum,, MD, MPH University of Washington
Study Director: Jared Baeten, MD, PhD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Connie Celum, Protocol Chair, University of Washington
ClinicalTrials.gov Identifier: NCT00557245     History of Changes
Other Study ID Numbers: 32528-A, IND 75,365;, 07-7454-A-01
Study First Received: November 8, 2007
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration
Kenya: Ethical Review Committee
Kenya: Institutional Review Board
Kenya: Pharmacy and Poisons Board
Kenya: Ministry of Health
Uganda: Ministry of Health
Uganda: National Council for Science and Technology
Uganda: National Drug Authority
Uganda: Research Ethics Committee

Keywords provided by University of Washington:
HIV infection
HIV uninfected partners
Double Blind
Placebo
Seroconversion
TDF
FTC TDF
Safety
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 20, 2014