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Preventing Sexual Transmission of HIV With Anti-HIV Drugs

NCT ID: NCT00074581

Last Updated: 2021-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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HIV Infections HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Participants will begin ART in addition to receiving HIV primary care

Group Type EXPERIMENTAL

Atazanavir

Intervention Type DRUG

300 mg taken orally once daily

Didanosine

Intervention Type DRUG

400 mg taken orally once daily

Efavirenz

Intervention Type DRUG

600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumarate

Intervention Type DRUG

200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudine

Intervention Type DRUG

300 mg taken orally once daily

Lopinavir/Ritonavir

Intervention Type DRUG

200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapine

Intervention Type DRUG

200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudine

Intervention Type DRUG

Dosage depends on weight

Tenofovir disoproxil fumarate

Intervention Type DRUG

300 mg taken orally once daily

Zidovudine/Lamivudine

Intervention Type DRUG

150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

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.

Group Type EXPERIMENTAL

Atazanavir

Intervention Type DRUG

300 mg taken orally once daily

Didanosine

Intervention Type DRUG

400 mg taken orally once daily

Efavirenz

Intervention Type DRUG

600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumarate

Intervention Type DRUG

200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudine

Intervention Type DRUG

300 mg taken orally once daily

Lopinavir/Ritonavir

Intervention Type DRUG

200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapine

Intervention Type DRUG

200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudine

Intervention Type DRUG

Dosage depends on weight

Tenofovir disoproxil fumarate

Intervention Type DRUG

300 mg taken orally once daily

Zidovudine/Lamivudine

Intervention Type DRUG

150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Interventions

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Atazanavir

300 mg taken orally once daily

Intervention Type DRUG

Didanosine

400 mg taken orally once daily

Intervention Type DRUG

Efavirenz

600 mg taken orally once daily

Intervention Type DRUG

Emtricitabine/Tenofovir disoproxil fumarate

200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Intervention Type DRUG

Lamivudine

300 mg taken orally once daily

Intervention Type DRUG

Lopinavir/Ritonavir

200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Intervention Type DRUG

Nevirapine

200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Intervention Type DRUG

Stavudine

Dosage depends on weight

Intervention Type DRUG

Tenofovir disoproxil fumarate

300 mg taken orally once daily

Intervention Type DRUG

Zidovudine/Lamivudine

150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily

Intervention Type DRUG

Other Intervention Names

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Reyataz Videx Sustiva Truvada Epivir 3TC Kaletra Viramune NVP Zerit d4T Viread TDF Combivir

Eligibility Criteria

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Inclusion Criteria

* 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


* Negative HIV test within 14 days of study entry


* 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

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HIV Prevention Trials Network

NETWORK

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myron S. Cohen, MD

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

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Fenway Community Health Ctr. CRS

Boston, Massachusetts, United States

Site Status

Gaborone CRS

Gaborone, , Botswana

Site Status

Hospital Geral de Nova Iguaçu CRS (HGNI CRS)

Nova Iguaçu, Rio de Janeiro, Brazil

Site Status

Hospital Nossa Senhora da Conceicao CRS

Port Alegre, Rio Grande do Sul, Brazil

Site Status

HSE-Hospital dos Servidores do Estado CRS

Rio de Janeiro, , Brazil

Site Status

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro, , Brazil

Site Status

NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS

Pune, Maharashtra, India

Site Status

NARI Clinic at NIV CRS

Pune, Maharashtra, India

Site Status

NARI Pune CRS

Pune, Maharashtra, India

Site Status

Chennai Antiviral Research and Treatment (CART) CRS

Chennai, Tamil Nadu, India

Site Status

Kisumu Crs

Kisumu, Nyanza, Kenya

Site Status

Blantyre CRS

Blantyre, , Malawi

Site Status

Malawi CRS

Lilongwe, , Malawi

Site Status

Soweto HPTN CRS

Johannesburg, Gauteng, South Africa

Site Status

Wits Helen Joseph Hospital CRS (Wits HJH CRS)

Johannesburg, Gauteng, South Africa

Site Status

CMU HIV Prevention CRS

Chiang Mai, , Thailand

Site Status

Parirenyatwa CRS

Harare, , Zimbabwe

Site Status

Countries

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United States Botswana Brazil India Kenya Malawi South Africa Thailand Zimbabwe

References

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Chan DJ. Fatal attraction: sex, sexually transmitted infections and HIV-1. Int J STD AIDS. 2006 Oct;17(10):643-51. doi: 10.1258/095646206780071018.

Reference Type BACKGROUND
PMID: 17059632 (View on PubMed)

Chan DJ. Factors affecting sexual transmission of HIV-1: current evidence and implications for prevention. Curr HIV Res. 2005 Jul;3(3):223-41. doi: 10.2174/1570162054368075.

Reference Type BACKGROUND
PMID: 16022655 (View on PubMed)

Davis CW, Doms RW. HIV transmission: closing all the doors. J Exp Med. 2004 Apr 19;199(8):1037-40. doi: 10.1084/jem.20040426. Epub 2004 Apr 12. No abstract available.

Reference Type BACKGROUND
PMID: 15078894 (View on PubMed)

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. doi: 10.1371/journal.pmed.0030079. Epub 2006 Feb 28.

Reference Type BACKGROUND
PMID: 16492075 (View on PubMed)

Odero I, Ondeng'e K, Mudhune V, Okola P, Oruko J, Otieno G, Akelo V, Gust DA. Participant satisfaction with clinical trial experience and post-trial transitioning to HIV care in Kenya. Int J STD AIDS. 2019 Jan;30(1):12-19. doi: 10.1177/0956462418791946. Epub 2018 Aug 29.

Reference Type DERIVED
PMID: 30157702 (View on PubMed)

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.

Reference Type DERIVED
PMID: 27424812 (View on PubMed)

Grinsztejn B, Hosseinipour MC, Ribaudo HJ, Swindells S, Eron J, Chen YQ, Wang L, Ou SS, Anderson M, McCauley M, Gamble T, Kumarasamy N, Hakim JG, Kumwenda J, Pilotto JH, Godbole SV, Chariyalertsak S, de Melo MG, Mayer KH, Eshleman SH, Piwowar-Manning E, Makhema J, Mills LA, Panchia R, Sanne I, Gallant J, Hoffman I, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Havlir D, Cohen MS; HPTN 052-ACTG Study Team. 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. Lancet Infect Dis. 2014 Apr;14(4):281-90. doi: 10.1016/S1473-3099(13)70692-3. Epub 2014 Mar 4.

Reference Type DERIVED
PMID: 24602844 (View on PubMed)

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.

Reference Type DERIVED
PMID: 21767103 (View on PubMed)

Other Identifiers

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10068

Identifier Type: REGISTRY

Identifier Source: secondary_id

HPTN 052

Identifier Type: -

Identifier Source: org_study_id