LOPINAVIR/RITONAVIR PLUS EFAVIRENZ VERSUS LOPINAVIR/RITONAVIR PLUS STAVUDINE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5142 will evaluate the safety and efficacy of three different anti-HIV drug regimens as first-line treatment for HIV infection. The effects of the regimens will also be assessed. The drug regimens are: lopinavir/ritonavir and efavirenz, lopinavir/ritonavir, stavudine (or zidovudine) and lamivudine. If a drug regimen fails to lower the viral load or if the virus becomes resistant to therapy, subjects will be switched to a different therapy. Six hundred sixty-six subjects will be randomized into one of the three treatment arms. Subjects will be followed for between 96 to 138 weeks, depending on when they enroll; study visits will be every four weeks up to week 32 and then every eight weeks thereafter. Assessments will include medical and medication histories, targeted physical exams, anthropomorphic measurements, laboratory evaluations, and a Dual energy x-ray absorptiometry scan (DEXA).