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

University of Washington

Status and phase: Completed; Phase 3

Conditions: HIV-1 Infections; HIV Infections

Treatments: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Drug: Placebo; Drug: Tenofovir Disoproxil Fumarate (TDF)

Study type: Interventional

Funder types: Other

Identifiers

NCT00557245

STUDY00000172

IND 75,365 ;

07-7454-A-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,758 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,758 participants in 3 patient groups, including a placebo group

Tenofovir Disoproxil Fumarate (TDF)

Active Comparator group

Description:

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

Treatment:

Drug: Tenofovir Disoproxil Fumarate (TDF)

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

Active Comparator group

Description:

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

Treatment:

Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

Placebo

Placebo Comparator group

Description:

Placebo TDF + Placebo FTC/TDF orally, once daily.

Treatment:

Drug: Placebo