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Home > "P" Clinical Trials Conditions > Preventing Sexual Transmission of HIV With Anti-HIV Drugs  Preventing Sexual Transmission of HIV With Anti-HIV Drugs
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
For Condition: HIV Infections,HIV Seronegativity
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),National Institute on Drug Abuse (NIDA),National Institute of Mental Health (NIMH)
Synopsis: 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.
Details: 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 if initiating ART in ART-naive, HIV infected people can prevent the sexual transmission of HIV among HIV-discordant couples. 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 87 months (7 years, 3 months). 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 only. All couples will receive HIV counseling and have their urine and blood collected at screening, enrollment, and at selected monthly, quarterly, and yearly intervals. They will be asked to periodically report information about their sexual history and adherence to the ART regimen.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for HIV Infected Partner: - Positive HIV test within 60 days of study entry - CD4 cell count between 300 and 500 cells/mm3 within 30 days of study entry Inclusion Criteria for HIV Uninfected Partner: - HIV uninfected - 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 3 times in the last 3 months - If pregnant or breastfeeding, is willing to be assigned to either arm of study - Agrees to use acceptable forms of contraception - 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 HIV antiretroviral therapy - Documented or suspected acute hepatitis within 30 days of study entry, if the infected partner's starting regimen in the study contains nevirapine - Current or previous AIDS-defining illness or opportunistic infection Exclusion Criteria for Both Partners: - History of injection drug use within 5 years of study entry - Receipt of an experimental HIV vaccine - 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
Total Enrollment: 3500
Location and Contact Information:
Overall Study Official:
MyronCohen, Study Chair, University of North Carolina
Additional Information:
Study ID Numbers: HPTN 052;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074581
Other Hiv Infections Studies:
1. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
2. Long-Term Effects of HIV Exposure and Infection in Children
3. Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers
4. HIV Prevention Preparedness Study in Russia, China, and India
5. BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in Women
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Preventing Sexual Transmission of HIV With Anti-HIV Drugs
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