A Study in couples in which one partner is infected with HIV and the other partner is not infected. The primary goal is to find out whether treating HIV infected partner with Anti-HIV drugs can prevent them from transmitting the virus to their partner through sex
- 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.
- Registration Number
- CTRI/2009/091/000644
- Lead Sponsor
- ational Institute of Health USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1750
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
Hemoglobin > 7.5 g/dL
Platelet count > 50,000/µL.
AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 x ULN
Total bilirubin < 2.5 x ULN
Calculated creatinine clearance > 60 mL/min (use the Cockcroft and Gault method to calculate)
Absolute neutrophil count > 750 mm3 or 0.750 x 109/L
Partner
-Negative HIV serology within 14 days prior to enrollment.
-Has a sexual partner infected with HIV 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.
Both Index Case and Partner:
-Men and women age > 18 years.
-Willing to disclose HIV test results to partner.
-Not intending to relocate out of the area for the duration of study participation and does not have a job or other obligations that may require long absences from the area.
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
-Incarceration in a correctional facility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HIV infection in partnersTimepoint: Throughout study
- Secondary Outcome Measures
Name Time Method Determine, characterize, and compare the rates of AIDS-defining illnesses, sexually transmitted diseases, opportunistic infections, and immune reconstitution syndromes, with regard to outcomes and survival as observed in different geographic settings and by antiretroviral treatment strategies.Timepoint: Throughout study