Preventing Sexual Transmission of HIV With Anti-HIV Drugs
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| ClinicalTrials.gov Identifier: NCT00074581 |
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Recruitment Status :
Completed
First Posted : December 17, 2003
Results First Posted : October 31, 2016
Last Update Posted : November 5, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 3526 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | February 2005 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Participants will begin ART in addition to receiving HIV primary care
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Drug: Atazanavir
300 mg taken orally once daily
Other Name: Reyataz Drug: Didanosine 400 mg taken orally once daily
Other Name: Videx Drug: Efavirenz 600 mg taken orally once daily
Other Name: Sustiva Drug: Emtricitabine/Tenofovir disoproxil fumarate 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Other Name: Truvada Drug: Lamivudine 300 mg taken orally once daily
Other Names:
Drug: Lopinavir/Ritonavir 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Other Name: Kaletra Drug: Nevirapine 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Other Names:
Drug: Stavudine Dosage depends on weight
Other Names:
Drug: Tenofovir disoproxil fumarate 300 mg taken orally once daily
Other Names:
Drug: Zidovudine/Lamivudine 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Other Name: Combivir |
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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 Name: Reyataz Drug: Didanosine 400 mg taken orally once daily
Other Name: Videx Drug: Efavirenz 600 mg taken orally once daily
Other Name: Sustiva Drug: Emtricitabine/Tenofovir disoproxil fumarate 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily
Other Name: Truvada Drug: Lamivudine 300 mg taken orally once daily
Other Names:
Drug: Lopinavir/Ritonavir 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily
Other Name: Kaletra Drug: Nevirapine 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily
Other Names:
Drug: Stavudine Dosage depends on weight
Other Names:
Drug: Tenofovir disoproxil fumarate 300 mg taken orally once daily
Other Names:
Drug: Zidovudine/Lamivudine 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily
Other Name: Combivir |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074581
Show 17 study locations
| Study Chair: | Myron S. Cohen, MD | University of North Carolina, Chapel Hill |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00074581 |
| Other Study ID Numbers: |
HPTN 052 10068 ( Registry Identifier: DAIDS ES ) |
| First Posted: | December 17, 2003 Key Record Dates |
| Results First Posted: | October 31, 2016 |
| Last Update Posted: | November 5, 2021 |
| Last Verified: | November 2016 |
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HIV Infections HIV Seronegativity |
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HIV Infections Infections Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Atazanavir Sulfate |
Tenofovir Lamivudine Zidovudine Emtricitabine Nevirapine Didanosine Stavudine Efavirenz HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |