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 125/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 the most recent viral load test prior to screening less than 500 copies/ml. Patients must be receiving 3 drug HAART containing an NNRTI, abacavir or PI for at least 90 days prior to enrollment and at least 1 PI or efavirenz for 30 days prior to enrollment.
A viral load of less than 50 copies/ml prior to enrollment.
Age at least 18 years and above.
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/microliters.
Written consent to participate in the trial.
Patient financially capable of purchasing the drugs uninterrupted for at least 72 weeks (the duration of the study).
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 Kaposi s sarcoma or candida or treated tuberculosis.
Use of experimental antiretroviral less than or equal to 6 months prior to enrollment. An exception may be made for hydroxeurea according to the judgment of the Principal Investigator.
Pregnancy or breastfeeding.
Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine history, physical examination, or screening laboratory studies. If an abnormality is a contraindication to a specific drug, an alternative drug within the same class may be used.
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. evidence of clinical resistance to licensed anti-retrovirals as indicated by clinical progression, an elevated viral load or declining CD4+ T cell count while receiving antiretroviral therapy, or receiving sub-optimal antiretroviral therapy prior to HAART.
Patients currently receiving nevirapine or abacavir are excluded.