Treatment De-Intensification and Residual HIV-1 in Youth

081 participants must first be enrolled in either ATN 061 or ATN 071 and meet the
eligibility criteria of those protocols in addition to those below.

Inclusion Criteria:

061 Participants

- Currently on treatment with an ATV/r-based HAART regimen (ATV/r, FTC, TDF is the
preferred regimen);

- HIV-1 viral load < 100 copies at week 24;

- CD4+ T cell count > 350 cells/mm3 at week 24; and

- Able to provide informed consent for the sub-study and adhere to the protocol.

071 Participants

- Initiated HAART according to current DHHS guidelines (CD4+ T cells < 350 cells/ mm3);

- Currently on treatment with a PI-containing HAART regimen; subjects taking a protease
inhibitor OTHER than ATV/r must receive approval by the team via the ATN QNS;

- Plasma HIV-1 viral load < 100 copies at week 24 on HAART; measurement to be collected
from clinical care results contained in the medical record at the clinical site
within +/- 30 days of week 24 on therapy;

- CD4+ T cell count > 350 cells/mm3 at week 24 on HAART; measurement to be collected
from clinical care results contained in the medical record at the clinical site
within +/- 30 days of week 24 on therapy; and

- Able to provide informed consent for the sub-study and adhere to the protocol.

General Exclusion Criteria:

- Currently enrolled in the Standard Care Arm of ATN 061;

- Pregnancy or breast feeding;

- Severe (Grade ≥ 3) anemia or other conditions that would not allow adequate blood
volume to be drawn;

- Active treatment for systemic infections;

- Treatment with immune modulators, including immunosuppressive or immune modulating
therapy (IL-2, intravenous gammaglobulin, and therapeutic or other experimental
vaccines including HIV-1 vaccine given for primary prevention at any time (short
courses (<14 days) of prednisone for reactive airway disease (RAD) are permitted);

- Active hepatitis B infection as defined by Hepatitis B antigen (Ag) positive;

- Disallowed Medications (see Section 5.3.2);

- Active drug or alcohol use or dependence that, in the opinion of the site personnel,
would interfere with adherence to the study; or

- History of chronic renal insufficiency or Grade 3 or greater serum creatinine.

061-Specific Exclusion Criteria

- History of an Acquired Immunodeficiency Syndrome (AIDS)-defining illness;

- Meets any ATN 061 exclusion criteria for de-intensification; or

- Meets any ATN 061 premature study discontinuation criteria.

071-Specific Exclusion Criteria: None