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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) HIV Prevention Trials Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00074581 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Atazanavir Drug: Didanosine Drug: Efavirenz Drug: Emtricitabine/Tenofovir disoproxil fumarate Drug: Lamivudine Drug: Lopinavir/Ritonavir Drug: Nevirapine Drug: Stavudine Drug: Tenofovir disoproxil fumarate Drug: Zidovudine/Lamivudine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 3500 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will begin ART in addition to receiving HIV primary care
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Drug: Atazanavir
300 mg taken orally once daily
Drug: Didanosine
400 mg taken orally once daily
Drug: Efavirenz
600 mg taken orally once daily
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Drug: Lamivudine
300 mg taken orally once daily
Drug: Lopinavir/Ritonavir
200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Drug: Nevirapine
200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Drug: Stavudine
Dosage depends on weight
Drug: Tenofovir disoproxil fumarate
300 mg taken orally once daily
Drug: Zidovudine/Lamivudine
150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
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2: Experimental
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.
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Drug: Atazanavir
300 mg taken orally once daily
Drug: Didanosine
400 mg taken orally once daily
Drug: Efavirenz
600 mg taken orally once daily
Drug: Emtricitabine/Tenofovir disoproxil fumarate
200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Drug: Lamivudine
300 mg taken orally once daily
Drug: Lopinavir/Ritonavir
200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Drug: Nevirapine
200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Drug: Stavudine
Dosage depends on weight
Drug: Tenofovir disoproxil fumarate
300 mg taken orally once daily
Drug: Zidovudine/Lamivudine
150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for HIV Infected Partner:
Inclusion Criteria for HIV Uninfected Partner:
Inclusion Criteria for Both Partners:
Exclusion Criteria for HIV Infected Partner:
Exclusion Criteria for Both Partners:
United States, Massachusetts | |
Fenway Community Health Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Robbie Singal, MPHTM 617-927-6021 rsingal@fenwayhealth.org | |
Botswana | |
Gaborone Prevention/Treatment Trials CRS | Not yet recruiting |
Gaborone, Botswana | |
Contact: Tumalano Sekoto, RN 267-39-31146 tsekoto@bhp.org.bw | |
Principal Investigator: Claire Moffat, MD, MPH | |
Brazil | |
Instituto de Pesquisa Clinica Evandro Chagas | Recruiting |
Rio de Janeiro, Brazil, 21045-900 | |
Contact: Beatriz Grinsztejn, MD, PhD 552 125 644933 gbeatriz@unisys.com.br | |
Hospital Geral de Nova Iguacu | Recruiting |
Rio de Janeiro, Brazil, 21045-900 | |
Contact: Jose Henrique Pilotto, MD 552 122 707064 pilotto@unisys.com.br | |
Hospital dos Servidores do Estado - Servico de Doe | Active, not recruiting |
Saude, Rio de Janeiro, Brazil, 20221-903 | |
Brazil, RS | |
Hospital Nossa Senhora da Conceicao | Recruiting |
Port Alegre, RS, Brazil, 91350 200 | |
Contact: Breno Riegel Santos, MD 55 51 3361 2911 breno@ghc.com.br | |
India | |
National AIDS Research Institute, Pune, India | Recruiting |
Pune, India | |
Contact: Manisha Ghate 91-20-712-1072 mghate@nari-icmr.res.in | |
Talera Municipal Hospital - NARI Clinic | Recruiting |
Pune, India | |
Contact: Manisha Ghate 91-20-712-1072 mghate@nari-icmr.res.in | |
Gadikhana Hospital - NARI Clinic | Recruiting |
Pune, India | |
Contact: Manisha Ghate 91-20-712-1072 mghate@nari-icmr.res.in | |
Jehangir Hospital and Medical Center - NARI Clinic | Recruiting |
Pune, India | |
Contact: Manisha Ghate 91-20-712-1072 mghate@nari-icmr.res.in | |
Y.R. Gaitonde Medical and Research Foundation, India | Recruiting |
Taramani, India | |
Contact: A. K. Krishnan 011-91-44-22542929 | |
Malawi | |
Ministry of Health & Population, Lilongwe Central | Recruiting |
Lilongwe, Malawi | |
Contact: David Chilongozi, MPH 01 265 755056 dchilongozi@malawi.net | |
Malawi College of Medicine, Queen Elizabeth Central Hospital | Recruiting |
Blantyre, Malawi | |
Contact: Newton Kumwenda, MPH, PhD 265 163 1527 jhopkins@sdnp.org.mw | |
South Africa, Gauteng | |
Soweto HPTN CRS | Not yet recruiting |
Johannesburg, Gauteng, South Africa | |
Contact: Puleng Dhlamini 27-11-9899709 dhlaminip@hivsa.com | |
Principal Investigator: Guy de Bruyn | |
Thailand | |
Research Institute for Health Sciences (RIHES) | Recruiting |
Chaing Mai, Thailand, 50202 | |
Contact: Peter Lange 66-53-221-966 | |
Family Health Center, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai Univ. | Recruiting |
Chiang Mai, Thailand, 50200 | |
Contact: Cholticha Ruangyuttikarn 66-53 221-966 ext 465 cholti@chiangmai.ac.th |
Study Chair: | Myron S. Cohen, MD | The University of North Carolina, Chapel Hill |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HPTN 052 |
Study First Received: | December 16, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00074581 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Infections HIV Seronegativity |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Lamivudine Zidovudine Reverse Transcriptase Inhibitors Emtricitabine Lopinavir Anti-Retroviral Agents Tenofovir Retroviridae Infections Tenofovir disoproxil Efavirenz |
HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Nevirapine Didanosine HIV Infections Ritonavir Sexually Transmitted Diseases |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Lopinavir Emtricitabine Therapeutic Uses Tenofovir Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Atazanavir Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Nevirapine |