Antiretroviral Therapy for Advanced HIV Disease in South Africa
Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
Participant gender:
Summary
This study will determine how well four different antiretroviral drug therapies work in
patients with advanced HIV disease. The trial is part of the South Africa-U.S. Project
Phidisa Programme - a collaboration between the South African Military Health Service (SAMHS)
of the South African National Defense Force (SANDF), the U.S. Department of Defense, and the
U.S. National Institutes of Health - to help prevent HIV transmission among South African
military and civilian employees and their families.
Members of the SANDF with HIV infection may be eligible for this study. HIV-infected family
members who are 14 years of age and older may also participate. All participants must have a
CD4 count of less than 200 or an AIDS-defining illness.
Participants are randomly assigned to one of the following four antiretroviral drug regimens,
which require taking 5 pills or more every day:
- AZT (zidovudine) + ddl (didanosine) + EFV (efavirenz)
- AZT (zidovudine) + ddl (didanosine) + r/LPV (lopinavir/ritonavir)
- D4T (stavudine) + 3TC (lamivudine) + EFV (efavirenz)
- D4T (stavudine) + 3TC (lamivudine) + r/LPV (lopinavir/ritonavir)
Patients are followed for up to 6 years. Clinic visits are scheduled once a month for the
first 3 months and then once every 3 months for the next five years. Patients undergo a
medical history, physical examination, and blood tests at each visit, and complete
questionnaires of behavior, quality of life, and force readiness every year.
Phase:
Phase 4
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)