Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-1 Infections; HIV Infections
Intervention: Tenofovir Disoproxil Fumarate (TDF) (Drug); Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Connie Celum,, MD, MPH, Study Chair, Affiliation: University of Washington Jared Baeten, MD, PhD, Study Director, Affiliation: University of Washington
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.
Clinical Details
Official title: Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected ParticipantsNumber of Participants With Serious Adverse Events (SAEs)
Secondary outcome: Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.Study Drug Adherence: Self-reported Missed Doses of Study Drug Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up Prevalence of Unprotected Sex During Follow-up Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug. Length Among Infants Born to Female Participants Taking Study Drug Weight Among Infants Born to Female Participants Taking Study Drug Head Circumference Among Infants Born to Female Participants Taking Study Drug
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.
This study was a 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. The HIV-1 uninfected partner was randomized in a 1: 1:1
ratio to one of three arms: once daily Tenofovir Disoproxil Fumarate (TDF),
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) or Placebo.
Couples were followed up to 36 months; the HIV uninfected partner attended monthly visits
and the HIV infected partner quarterly visits. All participants received a comprehensive
package of HIV prevention services including individual and couples counseling, free
condoms, and male circumcision referrals.
Participants who seroconverted during follow-up stopped the study drug but continued with
follow-up.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
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
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
Additional Information
Related publications: Mujugira A, Baeten JM, Donnell D, Ndase P, Mugo NR, Barnes L, Campbell JD, Wangisi J, Tappero JW, Bukusi E, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kidoguchi L, Panteleeff D, Krows M, Shah H, Revall J, Morrison S, Ondrejcek L, Ingram C, Coombs RW, Lingappa JR, Celum C; Partners PrEP Study Team. Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention. PLoS One. 2011;6(10):e25828. doi: 10.1371/journal.pone.0025828. Epub 2011 Oct 5.
Starting date: May 2008
Last updated: November 20, 2014
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