Preventing Sexual Transmission of HIV With Anti-HIV Drugs
This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
HIV Prevention Trials Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00074581
First received: December 16, 2003
Last updated: November 2, 2012
Last verified: November 2012
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Purpose
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 |
|---|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Formic acid
Stavudine
Zidovudine
Didanosine
Nevirapine
Lamivudine
Emtricitabine
Tenofovir
Efavirenz
Ritonavir
Lopinavir
Atazanavir
Tenofovir Disoproxil Fumarate
Atazanavir sulfate
Truvada
U.S. FDA Resources
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Recorded HIV infections in Arms 1 and 2 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time from enrollment to death [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Immunologic response of HIV infected partner: CD4 count over time, time from enrollment to immunologic failure, time from initiation of ART to immunologic failure, time from initiation of secondary regimen to immunologic failure [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Viral load in blood, semen, and vaginal secretions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Time to initiation of secondary regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Safety and toxicity [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- HIV drug resistance: prevalence of drug resistance, proportion of HIV infected partners acquiring a drug resistance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Time from enrollment to the time of first development and subsequent development of STDs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Adherence to drug regimen over time [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Sexual behavior over time following initiation of starting regimen and following initiation of a secondary regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Quality of life indicators over time following initiation of starting regimen and following initiation of a secondary regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Determine, characterize, and compare the effect of circumcision on HIV transmission in different geographic setting and by antiretroviral treatment strategies. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3500 |
| Study Start Date: | February 2005 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will begin ART in addition to receiving HIV primary care
|
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
|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074581
Locations
| United States, Massachusetts | |
| Fenway Community Health Ctr. CRS | |
| Boston, Massachusetts, United States, 02115 | |
| Botswana | |
| Gaborone Prevention/Treatment Trials CRS | |
| Gaborone, Botswana | |
| 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, 91350 200 | |
| Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | |
| Rio de Janeiro, Brazil | |
| HSE-Hospital dos Servidores do Estado CRS | |
| Rio de Janeiro, Brazil, 20221-903 | |
| India | |
| NARI Clinic at NIV CRS | |
| Pune, Maharashtra, India | |
| NARI Pune CRS | |
| Pune, Maharashtra, India | |
| NARI Clinic at Gadikhana Dr. Kotnis Municipal Dispensary CRS | |
| Pune, Maharashtra, India | |
| YRG CARE Medical Ctr., VHS Chennai CRS | |
| Taramani, India | |
| Kenya | |
| Kemri/Cdc Crs | |
| Kisumu, Kenya | |
| Malawi | |
| College of Med. JHU CRS | |
| Blantyre, Malawi | |
| University of North Carolina Lilongwe CRS | |
| Lilongwe, Malawi | |
| South Africa | |
| Soweto HPTN CRS | |
| Johannesburg, Gauteng, South Africa | |
| Wits HIV CRS | |
| Johannesburg, Gauteng, South Africa | |
| Thailand | |
| Chiang Mai Univ. AIDS Prevention CRS | |
| Chiang Mai, Thailand, 50202 | |
| Zimbabwe | |
| UZ-Parirenyatwa CRS | |
| Harare, Zimbabwe | |
Sponsors and Collaborators
HIV Prevention Trials Network
Investigators
| Study Chair: | Myron S. Cohen, MD | University of North Carolina, Chapel Hill |
More Information
Additional Information:
Publications:
Additional 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 History of Changes |
| Other Study ID Numbers: | HPTN 052, 10068 |
| Study First Received: | December 16, 2003 |
| Last Updated: | November 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Infections HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Didanosine Zidovudine Stavudine Nevirapine |
Lamivudine Tenofovir Tenofovir disoproxil Efavirenz Ritonavir Anti-HIV Agents Lopinavir Atazanavir Emtricitabine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013
