Gender: All
Maximum age: N/A
Minimum age: 18 Years
INCLUSION CRITERIA:
- Signed informed consent
- HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any
licensed* ELISA test; and confirmed by another test using a different method including
but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV
pro-viral DNA at any time prior to study entry.
- Age greater than or equal to 18 years
- Karnofsky performance score greater than or equal to 80 (an indication that the
participant can perform normal activities)
- Perceived life expectancy of at least 6 months
- For women of child-bearing potential, willingness to use contraceptives as described
in the product information of the ART drugs they are prescribed
- Two CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60
days before randomization
- The term licensed refers to an FDA-approved kit or, for sites located in
countries other than the United States, a kit that has been certified or licensed
by an oversight body within that country. Confirmation of the initial test result
must use a test method that is different than the one used for the initial
assessment.
EXCLUSION CRITERIA:
- Any previous use of ART or interleukin-2 (IL-2)
- Diagnosis of any clinical AIDS event before randomization (including esophageal
candidiasis and chronic Herpes simplex infection)
- Presence of HIV progression such as oral thrush, unexplained weight loss, or
unexplained fever
- Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass
grafting, stroke) within 6 months before randomization
- Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6
months before randomization
- Dialysis within 6 months before randomization
- Diagnosis of decompensated liver disease before randomization
- Current imprisonment, or compulsory detention (involuntary incarceration) for
treatment of a psychiatric or physical illness
- Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is
required within 14 days before randomization for women of child-bearing potential)
