Preventing Sexual Transmission of HIV With Anti-HIV Drugs

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074581
• Other study ID #: HPTN 052
• Secondary ID: 10068
• Status: Completed
• Phase: Phase 3
• Start date: February 2005
• Est. completion date: May 2015

Study information

• Verified date: November 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3526
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir
300 mg taken orally once daily
• Didanosine
400 mg taken orally once daily
• Efavirenz
600 mg taken orally once daily
• Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
• Lamivudine
300 mg taken orally once daily
• Lopinavir/Ritonavir
200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
• Nevirapine
200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
• Stavudine
Dosage depends on weight
• Tenofovir disoproxil fumarate
300 mg taken orally once daily
• Zidovudine/Lamivudine
150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	HIV Prevention Trials Network

Countries where clinical trial is conducted

United States,  Zimbabwe,  Botswana,  Brazil,  India,  Kenya,  Malawi,  South Africa,  Thailand, 

References & Publications (4)

Chan DJ. Factors affecting sexual transmission of HIV-1: current evidence and implications for prevention. Curr HIV Res. 2005 Jul;3(3):223-41. Review. — View Citation

Chan DJ. Fatal attraction: sex, sexually transmitted infections and HIV-1. Int J STD AIDS. 2006 Oct;17(10):643-51. Review. — View Citation

Davis CW, Doms RW. HIV transmission: closing all the doors. J Exp Med. 2004 Apr 19;199(8):1037-40. Epub 2004 Apr 12. Review. — View Citation

Gupta K, Klasse PJ. How do viral and host factors modulate the sexual transmission of HIV? Can transmission be blocked? PLoS Med. 2006 Feb;3(2):e79. Epub 2006 Feb 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms	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
Primary	All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms	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

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