Phase 3 N=4,758 Randomized Quadruple-blind Prevention

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

HIV-1 Infections · HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00557245 ↗

Enrolled (actual)

4,758

Serious AEs

7.4%

Results posted

Nov 2014

Primary outcome: Primary: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants — 0.65; 0.50; 1.99 events per 100 person years — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tenofovir Disoproxil Fumarate (TDF) (Drug); Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants	0.65; 0.50; 1.99	<0.001 sig
PRIMARY Number of Participants With Serious Adverse Events (SAEs)	118; 115; 118	1.00
SECONDARY Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.	97; 97; 97	—
SECONDARY Study Drug Adherence: Self-reported Missed Doses of Study Drug	15; 15; 15; 4; 4; 4	—
SECONDARY Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC	1; 1; 0	—
SECONDARY Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up	102; 76; 85	0.24
SECONDARY Prevalence of Unprotected Sex During Follow-up	14; 13; 13	0.32
SECONDARY Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.	4; 4; 5	0.51
SECONDARY Length Among Infants Born to Female Participants Taking Study Drug	-0.006; 0.036; -0.033	0.42
SECONDARY Weight Among Infants Born to Female Participants Taking Study Drug	-0.021; 0.009; -0.056	0.02 sig
SECONDARY Head Circumference Among Infants Born to Female Participants Taking Study Drug	-0.057; -0.005; -0.079	0.35

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00557245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.