Inclusion Criteria:

• Subject is age 18 years or older.
• Subject is HIV-infected as confirmed by positive enzyme immunoassay (EIA) and western blot testing, by an HIV viral load >5,000 copies, or by genotyping that confirms infection with HIV.

• For highly active antiretroviral therapy (HAART)-naïve subjects (i.e. persons with no prior substantial antiretroviral [ARV] exposure):

  • Subject’s CD4+ cell count is between 100 and 500 cells/mm³
  • Subject has not ever received more than 30 days consecutive or non-consecutive treatment with any ARVs regardless of reason (e.g., pharmacokinetic study, post-exposure prophylaxis, prevention of vertical transmission in pregnancy).

• For HAART-exposed subjects (i.e. persons who have taken or are taking HAART at the time of enrollment):

  • Subject’s CD4+ cell count is >100 cells/mm³

  • Subject’s previous and/or current treatment with ARVs has consisted only of HAART (of any duration and in any number of regimens) defined as:

    • >3 antiretroviral drugs from at least 2 antiretroviral drug classes (nucleotide reverse transcriptase inhibitors [NRTI], non-nucleoside reverse transcriptase inhibitors [NNRTI], protease inhibitors [PI]); or,
    • >3 NRTIs.
• Other antiretroviral combinations that in the course of the study are developed and become accepted as equivalent to best available therapy.
• Subject has received only HAART either as prescribed therapy or in the context of a supervised study.
• Subject has completed at least two visits within the past year to the clinical facility where the patient is eligible for enrollment.
• Subject is anticipated to continue receiving care at the clinical facility where she or he is eligible for enrollment for at least 2 years.
• Subject is able to understand and sign an informed consent.

Exclusion Criteria:

• Subject is pregnant.
• Subject is incarcerated. (footnote 1)

• Within the past 60 days subject has:

  • Had an AIDS-defining opportunistic infection or illness.
  • Received any chemotherapy or immunomodulating therapy (e.g., glucocorticoids, interleukin-2, interferon). (footnote 2)
• Subject is expected to live less than 2 years.
• Subject is unable or unwilling to complete any part of the study protocol.
• Subject is considered by the principal investigator to be ineligible for enrollment for any other reason, including but not limited to remote geographic location, experience in prior research studies, inconsistency as a historian, etc.
• Subject is unable or refuses to provide informed written consent due to any physical or psychological incapacity (e.g., persistent vegetative state, mental disability).

Footnotes:

1. Participants will be temporarily suspended from the study while pregnant or incarcerated after enrollment.
2. Cases where eligibility by these criteria is unclear or requires special consideration will be referred to the Executive Committee for a final decision.