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Antiretroviral Therapy for Advanced HIV Disease in South Africa
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.
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