PET/CT Imaging Companion Study To ACTG A5314

• Inclusion Criteria:

1.1 HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies.

WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.

1.2 Currently on continuous ART for ≥24 weeks prior to study entry. This is defined as continuous active therapy for the 24-week period prior to study entry with no treatment interruption longer than 7 consecutive days and a total duration off treatment of no more than 14 days in the 90 days prior to study entry.

1.3 CD4+ T-cell count ≥400 cells/mm3 obtained within 60 days prior to study entry by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.

1.4 HIV-1 RNA level below the limit of quantification using a FDA-approved assay for at least 24 weeks prior to study entry and confirmed within 60 days prior to study entry. The assay used for eligibility can be performed by any US laboratory that has a CLIA certification or its equivalent.

NOTE: Single determinations that are between the assay quantification limit and 200 copies/mL are allowed as long as the preceding and subsequent determinations are below the level of quantification.

1.5 The following laboratory values obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent;

• Fasting glucose 3000/mm3
• Hemoglobin >12.0 g/dL
• Platelets >150,000/mm3

1.6 Females subjects who are postmenopausal (i.e., of non-childbearing potential), defined as having either:

• Appropriate medical documentation of prior hysterectomy and/or complete bilateral oophorectomy (i.e., surgical removal of the ovaries, resulting in "surgical menopause" and occurring at the age at which the procedure was performed), OR
• Permanent cessation of previously occurring menses as a result of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., "spontaneous menopause"). Hormonal deficiency should be properly documented in the case of suspected spontaneous menopause as follows:
• If age >54 years and with the absence of normal menses for at least 24 consecutive months: serum follicle stimulating hormone (FSH) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed;
• If age ≤ 54 years and with the absence of normal menses for at least 24 consecutive months: Negative serum or urine (β-HCG) performed within 48 hours prior to study entry with concurrently elevated serum FSH level in the post-menopausal range, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assays are performed.

1.7 Male subjects must agree not to participate in a conception process (i.e., active attempt to impregnate, sperm donation). If participating in sexual activity that could lead to pregnancy, the male subject must agree to the use of TWO reliable forms of contraceptives simultaneously while on study and for a minimum of 3 months after therapy.

At least TWO of the following contraceptives MUST be used appropriately by male subjects and their female pa