ATN 061 HIV-Related/AIDS-Defining Additional Diagnoses/Recurrent Episodes Dataset in Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/ritonavir (ATV/r) in Adolescents and Young Adults with CD4 + T Cells > 350 cells/mm3 Initiating HAART

Data from HIV and Non-HIV Diagnoses Form [CRF 5, HIV-related/AIDS-defining diagnoses – recurrent episodes/additional diagnoses]
Study Description
A randomized, proof-of-concept study of adolescents and young adults aged 18-24 years with confirmed HIV acquired after age 9 with CD4+ T cells above 350 cells/mm3 who were randomized 3:1 to begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended NRTI backbone with ATV/r upon entry. Subjects in the experimental group who achieved virologic control by week 24 and maintained good control through 48 weeks would de-intensify to ATV/r alone and be followed for an additional two years. Subjects randomized to the standard care arm began HAART with TDF/FTC/ATV/r, AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen and followed for a total of three years. Subjects on the standard care arm would begin therapy when the CD4+ T cell count dropped below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician. Some biospecimens are available; for inquiries, please contact Dr. John Sleasman ([e-mail]). Adolescents and young adults aged 18-24 years with confirmed HIV acquired after age 9