This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then during de-intensification.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: 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.
Progression: 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. Treatment: 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. Duration: three years.
Children's Hopsital of Los Angeles
Los Angeles, California, United States
Difference in CD4+ T Cell Percentage Between Week 0 and Week 48
Time frame: Week 0 and Week 48
Difference in CD4+ T Cell Percentage Between Week 48 and Week 152
Time frame: 152 Weeks
Difference in CD4+ T Cell Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ T Cell Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ TCM Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ TEMRo Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ TEMRa Count Between Week 0 and Week 48
Time frame: 48 weeks
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University of Southern California - IMPAACT Site
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Children's Hospital of Denver - IMPAACT Site
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Howard University - IMPAACT Site
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
University of Southern Florida College of Medicine
Tampa, Florida, United States
Stoger Hospital of Cook County
Chicago, Illinois, United States
...and 13 more locations
Difference in CD4+ TEMRa Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ TCM Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ TCM Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ TEMRo Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ TEMRo Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ TEMRa Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ TEMRa Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152
Time frame: 152 weeks