A PHASE III, RANDOMIZED, OPEN-LABEL, COMPARISON OF LOPINAVIR/RITONAVIR PLUS E

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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. The study procedures will consists of subjects taking part in a total of 17 visits over a period of at least 96 weeks or as long as 138 weeks depending on when subject joins. There will be a screening visit and a pre-entry visit to determine eligibility for study. At this visit, the following will be done: taking medical history and information regarding medications subject is currently taking; subject will be asked about any signs or symptoms he/she may have; a physical examination, including a recording of blood pressure, pulse, respiration, temperature, height, and weight; blood will be drawn for various laboratory tests; if subject is a woman able to become pregnant, either she will give a urine specimen or an additional 1 teaspoon of blood will be drawn for a pregnancy test. Pregnant women are not allowed in this study. Step 1. If a patient is eligible, he/she will be randomized to receive: a) Lopinavir/Ritonavir (LPV/r) + Stavdine extended release (d4T XR) (or zidovudine [ZVD])+Lamivudine (3TC); b) Efavirenz (EFV) + Stavudine (drT XR) or Zidovudine (ZDV) + Lamivudine (3TC), or; c) Lopinavir/Ritonavir (LPV/r) + Efavirenz (EFV). Step II. If subjects experience toxicity to one component of the regimen, they will be randomized to Step II; drug substitutions within the same class of drugs will be recommended. Step III. If subjects experience virologic failure, experience toxicity to more than one component of the step I regimen, or experience toxicities to one component of the step II regimen, they will be switched to a recommended second regimen based on resistance testing. At entry a visit will be conducted, at which time the following will be performed: subject will be asked about any medicine changes as well as any symptoms subject may have; if subject is a woman, she will be asked some gynecological status questions; a complete physical examination, including measuring subjects' vital signs; a brief physical examination and waist and hips will be measured; blood will be drawn for laboratory tests; subject will be asked to complete several short questionnaires about body proportions and any symptoms he/she may have. Subject will have a whole-body, dual-energy x-ray absorption (DEXA) scan (bone and fat scan).