Phase 3
Completed N=3,556
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
Source: ClinicalTrials.gov NCT00074581 ↗Enrolled (actual)
3,556
Serious AEs
59.4%
Results posted
Oct 2016
Primary outcomePrimary: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms — 0.07; 1.03 event rate per 100 person-yr — p=<0.0001
◆ Published Evidence
Highly cited
6,967citations · ~464 / year
Prevention of HIV-1 infection with early antiretroviral therapy.
Summary
This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
Linked Publications (4)
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Prevention of HIV-1 infection with early antiretroviral therapy.
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Antiretroviral Therapy for the Prevention of HIV-1 Transmission.
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Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial.
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Participant satisfaction with clinical trial experience and post-trial transitioning to HIV care in Kenya.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms |
0.07; 1.03 | <0.0001 sig |
| PRIMARY All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms |
0.44; 1.41 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria for HIV Infected Partner:
- Positive HIV test within 60 days of study entry
- CD4 count between 350 and 550 cells/mm3 within 30 days of study entry
- If pregnant or breastfeeding, willing to be randomized to either arm of the study
Inclusion Criteria for HIV Uninfected Partner:
- Negative HIV test within 14 days of study entry
Inclusion Criteria for Both Partners:
- Plans to maintain sexual relationship with partner
- Reports having sex (vaginal or anal) with partner at least three times in the last 3 months
- Willing to disclose HIV test results to partner
- Plans to stay in the area and does not have a job or other obligations that may require long absences during the duration of the study
Exclusion Criteria for HIV Infected Partner:
- Current or previous use of any ART. Participants who previously took a short-term course of ART for prevention of mother-to-child transmission of HIV are not excluded.
- Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine or atazanavir
- Current or previous AIDS-defining illness or opportunistic infection
- Documented or suspected acute hepatitis within 30 days prior to study entry
- Acute therapy of serious medical illnesses within 14 days prior to study entry
- Radiation therapy or systemic chemotherapy within 45 days prior to study entry
- Immunomodulatory or investigational therapy within 30 days prior to study entry
- Active drug or alcohol dependence that, in the opinion of the investigator, would interfere with the study
- Vomiting or inability to swallow medications
- Require certain medications
- Allergy or sensitivity to any of the study drugs
Exclusion Criteria for Both Partners:
- History of injection drug use within 5 years of study entry
- Previous and/or current participation in an HIV vaccine study
- Currently detained in jail or for treatment of a psychiatric or physical illness
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- Certain abnormal laboratory values
Data sourced from ClinicalTrials.gov (NCT00074581) and the linked publication. 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. Informational only — not medical advice.