CTRI/2009/091/000644
Completed
Phase 3
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
ational Institute of Health USA0 sites1,750 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Find out whether treating HIV infected people with anti HIV drugs will prevent them from transmitting the virus to their partner through sex.
- Sponsor
- ational Institute of Health USA
- Enrollment
- 1750
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Couples are defined as sexual partners same or opposite sex who are married have been
- •living together or consider each other a primary partner. They must have been together for a minimum of three months and at the time of study enrollment expect to maintain their relationship for the duration of the study.
- •Index Case:
- •\-Positive HIV serology obtained within 60 days prior to enrollment
- •\-Has a sexual partner (as defined above) who is not infected with HIV (documented by negative HIV serology) and who is willing to participate in the study.
- •\-Plans to maintain a sexual relationship with the person who is enrolled in the study with them.
- •\-Reports having sex (vaginal or anal) with partner at least 3 times in the last 3 months.
- •\-If pregnant or breastfeeding during screening or at the time of enrollment, willing to be randomized to either arm of the study.
- •\-The following conditions must be met for laboratory parameters within 60 days prior to enrollment:
- •CD4\+ cell count of 350\-550 cells/mm3
Exclusion Criteria
- •Index Case:
- •\-Current or previous AIDS\-defining illness (as defined in Appendix III).
- •\-Current or previous use of any ART drugs
- •\-Documented or suspected acute hepatitis within 30 days prior to enrollment, irrespective of AST (SGOT) and ALT (SGPT) values.
- •\-Acute therapy for serious medical illnesses, chronic, acute, or recurrent infections in the opinion of the site investigator
- •\-Radiation therapy or systemic chemotherapy, any immunomodulator or other investigational therapy, Active drug or alcohol use or dependence, Allergy/sensitivity to any study drugs.
- •Both Index Case and Partner:
- •\-Reports a history of injection drug use within the last five years.
- •\-Previous and/or current participant in an HIV vaccine study.
- •\-Any condition that, in the opinion of the study staff, would make participation in the study unsafe
Outcomes
Primary Outcomes
Not specified
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