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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 Participants

Number 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

Page last updated: August 23, 2015

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