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.
Conditions
Interventions
Intervention1: immediate ART arm: The study partcipant on this arm will receive immediate ART therapy plus HIV primary care
Control Intervention1: Delayed ART arm: Stdy participant will receive only H
Sponsors
National Institute of Health USA
Eligibility
Inclusion 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 Hemoglobin > 7.5 g/dL Platelet count > 50,000/µL. AST (SGOT), ALT (SGPT), and alkaline phosphatase Total bilirubin 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.
Exclusion criteria
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 -Incarceration in a correctional facility
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Primary
| Measure | Time frame |
|---|---|
| HIV infection in partnersTimepoint: Throughout study | — |
Countries
Botswana, Brazil, India, Malawi, South Africa, Thailand, Zimbabwe
Contacts
Public ContactDrSheela Godbole
National AIDS Research Institute
Outcome results
None listed