A randomized factorial trial comparing 4 treatment regimens in treatment-naive HIV-infected persons with AIDS and/or a CD4 cell count <200 cells/μL in South Africa.

ABSTRACT:

Background

Few randomized trials comparing antiretroviral therapy (ART) regimens have been conducted in resource-limited settings.

Methods

In the Republic of South Africa, antiretroviral-naive human immunodeficiency virus (HIV)-infected individuals >14 years old with a CD4 cell count <200 cells/μL or a prior AIDS diagnosis were randomized to receive efavirenz (EFV) or lopinavir/ritonavir (LPV/r) with either zidovudine (ZDV) plus didanosine (ddI) or stavudine (d4T) plus lamivudine (3TC) in an open-label, 2-by-2 factorial study and followed up for the primary outcome of AIDS or death and prespecified secondary outcomes, including CD4 cell count and viral load changes, treatment discontinuation, and grade 4 events.

Results

In total, 1771 persons were randomized and follo

SUBMITTER: Phidisa II Writing Team for Project Phidisa 

PROVIDER: S-EPMC3008165 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature