Intermittent vs. Continuous HAART to Treat Chronic HIV Infection

INCLUSION CRITERIA: Documentation of HIV-1 infection by licensed ELISA test kit and confirmed by a second method (e.g. Western Blot). Absolute CD4+ T-cell count of greater than or equal to 175/mm(3) within 30 days before randomization (For patients who are status post-splenectomy, also CD4+ T-cell greater than 20%). If the CD4+ T cell count is less than or equal to 200 cells/mm(3), the patient must be receiving PCP prophylaxis. Receiving at least 3-drug HAART with at least 1viral load test less than 500 copies/ml and within at least 6 months screening. Patients must be receiving an NNRTI or a PI at enrollment. A viral load of less than 50 copies/ml prior to enrollment. Age at least 18 years. For women of childbearing potential, a negative pregnancy test (serum or urine) is required within 14 days prior to randomization. Laboratory values (within 30 days prior to randomization): AST no more than 5 X the upper limit of normal (ULN). Total or direct bilirubin no more than 2 X ULN unless there is a pattern consistent with Gilbert's syndrome or the patient is receiving indinavir. Creatinine no more than 2.0 mg/dL. Platelet count at least 50,000/microliter. EXCLUSION CRITERIA: Concurrent malignancy, or any other disease state, requiring cytotoxic chemotherapy. Symptomatic for significant HIV-related illnesses, such as opportunistic infections and malignancies other than mucocutaneous Kaposi's sarcoma. A history of AIDS defining opportunistic infections other than mucocutaneous candida. Use experimental antiretrovirals less than or equal to 6 months prior to enrollment. An exception may be made for hydroxyurea according to the judgment of the Principal Investigator. Patients receiving IL-2 will be eligible, and will be required to cycle during an on-HAART period if they are randomized to the intermittent arm. Pregnant or breastfeeding. Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine history, physical examination, or screening laboratory studies. Psychiatric illness that, in the opinion of the PI, might interfere with study compliance. Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety. Refusal to practice safe sex or use precautions against pregnancy (effective birth control with barrier contraceptives or abstinence). Known history or laboratory evidence of chronic hepatitis B infection including surface antigen positivity. Receiving salvage HAART, i.e. no evidence of clinical resistance to licensed anti-retrovirals. Patients receiving nevirapine, abacavir amd single protease inhibitor regimes at the time of enrollment. Patients receiving these medications may switch to other approved agents, and if the plasma viremia remains less than 50 copies/ml at least 30 days later, they would be eligible for enrollment. Patients on the continuous arm may receive nevirapine or abacavir regimens while participating in that arm.