NCT00491556.

Trial name or title	Early initiation of HAART
Methods	This is a randomized, proof of concept study of youth 18‐ 24 years of age with confirmed HIV after age 9 with CD4+ T cells above 350 cells/mm3 who are 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 or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de‐intensify to ATV/r alone and will be followed for two years. Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care.
Participants	Age 18 yrs and 0 days to 24 yrs and 364 days with CD4+ T cells >350/mm3 as determined by two consecutive measures within 6 months of entry, with second measure being collected at pre‐entry. Infected with HIV after age 9
Interventions	Experimental: Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de‐intensify to ATV/r alone and will be followed for an additional two years Control: Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.
Outcomes	Primary Outcome: Ability to maintain or enhance HAART‐associated quantitative changes in CD4+ T cell percentages achieved during HAART following therapy de‐intensification to ATV/r in adolescents and young adults who began treatment prior to meeting DHHS guidelines. Secondary Outcomes: Quantitative and qualitative changes in T cell subsets percentage in those initiating HAART prior to current guidelines followed by de‐intensification and in subjects initiating HAART by current DHHS guidelines Ability to maintain decreases in T cell activation achieved during HAART following therapy de‐intensification Ability to maintain virologic control following de‐intensification in adolescents treated with HAART prior to meeting DHHS guidelines Impact of early HAART initiation on thymic output Determine the emergence of drug resistance in subjects who fail therapy de‐intensification Evaluate the safety of initiating ART prior to significant CD4+ T cell loss with respect to emergence of drug associated toxicity and drug resistance Monitor prevalence of genotypic drug resistance within an ARV naïve or minimally exposed adolescent and young adult population; evaluate the associations of subject demographic and clinical variables with presence of genotypic mutation
Starting date	October 2007
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