At a glance
ClinicalIndex Comparison Record- ✓HIV-positive diagnosis confirmed from PHIDISA I or accredited source
- ✓CD4+ cell count <200 cells/μL (or ≤14% post-splenectomy) and/or any AIDS-defining illness (current or historical)
- ✓Antiretroviral treatment-naive or treated for post-exposure prophylaxis only without becoming HIV infected
- ✓Age ≥14 years
- ✕Any history of pancreatitis or serious pathology indicating increased risk for pancreatitis
- ✕Current requirement for medication contraindicated with PHIDISA II study drugs
- ✕Active tuberculosis requiring rifampicin (patients should defer screening until maintenance anti-tubercular regimen without rifampicin)
- ✕Pregnancy (enrollment possible post-delivery)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL
In Brief
A Phase 4 clinical trial evaluating Zidovudine, Stavudine, and 4 other interventions for HIV. Completed, enrolled 1,771 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
600 mg once daily
40 mg once daily
\<60 kg/125 mg twice daily or \>60kg/200 mg twice daily
300 mg once daily
600 mg once daily
r/LPV 400mg/100mg twice daily