ACTG 384 is a 3 year long study for HIV+ subjects who have never used any antiretroviral medication. This study has built-in salvage therapy options (Step 2 and Step 3) for subjects who do not respond to the initial treatment (known as Step 1). Included in this study is a metabolic substudy (A5005s) which looks at what kind of effect the antiretrovirals have on lipid levels, lipodystrophy and glucose in subjects who are naive to those drugs and then begin taking them. The GCRC will only be involved in the main study (ACTG 384) if a subject fails the step 1 or step 2 drug regimen and comes into the GCRC for one 6 hour stay for pharmacokinetics before starting the new drug regimen. The ACTU clinic will perform the evaluation for the main study. The GCRC will be used only if a patient fails Step 1 or Step 2 study therapy. If a patient fails, they will be seen in the GCRC for 6 hr. PK visit (see page 58 of the main protocol). The GCRC will be involved in the metabolic substudy (A5005s) if the subject consents to participate in the substudy. The subject will have an approximately 3-hour stay at day of entry into the main study (ACTG 384) and the metabolic substudy (A5005s) to have 2 blood draws, sample processing, 30 minute OGTT, fasting weight, body measurments, DEXA, BIA, and body image questionnaire (the last three will be performed or arranged by the ACTU study nurse). This visit will be repeated every 16 weeks until the end of the study (See Appendix IV).
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