Preventing Sexual Transmission of HIV With Anti-HIV Drugs

November 3, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Initiation of antiretroviral therapy (ART) in the HIV infected population has been shown to dramatically reduce the morbidity and mortality of HIV infection through sustained reduction in HIV viral replication. However, such therapy does not cure HIV infection or prevent the spread of the virus. ART may, however, make HIV infected people less contagious by lowering plasma HIV-1 RNA levels, compared with people not on ART. This study seeks to determine whether initiating ART in ART-naive, HIV infected people can prevent the sexual transmission of HIV among HIV-discordant couples, as well as to demonstrate whether quality of life changes with the initiation of ART. Both opposite and same sex couples will be recruited at study sites in Brazil, India, Malawi, Thailand, the United States, and Zimbabwe for this study.

Participating couples will be enrolled for approximately 78 months (6.5 years). Couples will be randomly assigned to one of two arms. HIV infected partners in Arm 1 will begin ART in addition to receiving HIV primary care. HIV infected partners in Arm 2 will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART. All couples will receive HIV counseling and have their urine and blood collected at screening and enrollment, and at selected monthly, quarterly, and yearly intervals. They will be asked to periodically report information about their adherence to the ART regimen.

Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.

Study Type

Interventional

Enrollment (Actual)

3526

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
      • Gaborone, Botswana
        • Gaborone CRS
  • Brazil
      • Rio de Janeiro, Brazil, 20221-903
        • HSE-Hospital dos Servidores do Estado CRS
      • Rio de Janeiro, Brazil, 21040-360
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
    • Rio De Janeiro
      • Nova Iguacu, Rio De Janeiro, Brazil, 26030-380
        • Hospital Geral de Nova Iguaçu CRS (HGNI CRS)
    • Rio Grande Do Sul
      • Port Alegre, Rio Grande Do Sul, Brazil, 91350 200
        • Hospital Nossa Senhora da Conceicao CRS
  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411026
        • NARI Pune CRS
      • Pune, Maharashtra, India, 411002
        • NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS
      • Pune, Maharashtra, India, 411011
        • NARI Clinic at NIV CRS
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600113
        • Chennai Antiviral Research and Treatment (CART) CRS
  • Kenya
    • Nyanza
      • Kisumu, Nyanza, Kenya, 40100
        • Kisumu Crs
  • Malawi
      • Blantyre, Malawi
        • Blantyre CRS
      • Lilongwe, Malawi
        • Malawi CRS
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2092
        • Wits Helen Joseph Hospital CRS (Wits HJH CRS)
      • Johannesburg, Gauteng, South Africa, 2001
        • Soweto HPTN CRS
  • Thailand
      • Chiang Mai, Thailand, 50202
        • CMU HIV Prevention CRS
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health Ctr. CRS
  • Zimbabwe
      • Harare, Zimbabwe
        • Parirenyatwa CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will begin ART in addition to receiving HIV primary care
Drug: Atazanavir
300 mg taken orally once daily
Other Names:
  • Reyataz
Drug: Didanosine
400 mg taken orally once daily
Other Names:
  • Videx
Drug: Efavirenz
600 mg taken orally once daily
Other Names:
  • Sustiva
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Other Names:
  • Truvada
Drug: Lamivudine
300 mg taken orally once daily
Other Names:
  • 3TC
  • Epivir
Drug: Lopinavir/Ritonavir
200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Other Names:
  • Kaletra
Drug: Nevirapine
200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Other Names:
  • Viramune
  • NVP
Drug: Stavudine
Dosage depends on weight
Other Names:
  • Zerit
  • d4T
Drug: Tenofovir disoproxil fumarate
300 mg taken orally once daily
Other Names:
  • TDF
  • Viread
Drug: Zidovudine/Lamivudine
150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Other Names:
  • Combivir
Experimental: 2

Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.

Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible.
Drug: Atazanavir
300 mg taken orally once daily
Other Names:
  • Reyataz
Drug: Didanosine
400 mg taken orally once daily
Other Names:
  • Videx
Drug: Efavirenz
600 mg taken orally once daily
Other Names:
  • Sustiva
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Other Names:
  • Truvada
Drug: Lamivudine
300 mg taken orally once daily
Other Names:
  • 3TC
  • Epivir
Drug: Lopinavir/Ritonavir
200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Other Names:
  • Kaletra
Drug: Nevirapine
200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Other Names:
  • Viramune
  • NVP
Drug: Stavudine
Dosage depends on weight
Other Names:
  • Zerit
  • d4T
Drug: Tenofovir disoproxil fumarate
300 mg taken orally once daily
Other Names:
  • TDF
  • Viread
Drug: Zidovudine/Lamivudine
150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Other Names:
  • Combivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Time Frame: Throughout study
incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.
Throughout study
All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
Time Frame: Throughout study
All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

HIV Prevention Trials Network

Investigators

  • Study Chair: Myron S. Cohen, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 16, 2003

First Submitted That Met QC Criteria

December 16, 2003

First Posted (Estimate)

December 17, 2003

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPTN 052
  • 10068 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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