Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r)

Not Applicable

Completed

Conditions: HIV Infections

Registration Number: NCT00491556

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in CD4+ T Cell Percentage Between Week 0 and Week 48	Week 0 and Week 48
Difference in CD4+ T Cell Percentage Between Week 48 and Week 152	152 Weeks

Secondary Outcome Measures

Name	Time	Method
Difference in CD8+ TEMRo Count Between Week 0 and Week 48	48 weeks
Difference in CD8+ TEMRa Count Between Week 0 and Week 48	48 weeks
Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152	152 weeks
Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48	48 weeks
Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48	48 weeks
Difference in CD4+ T Cell Count Between Week 48 and Week 152	152 weeks
Difference in CD4+ TEMRa Count Between Week 48 and Week 152	152 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48	48 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152	152 weeks
Difference in CD8+ TCM Count Between Week 0 and Week 48	48 weeks
Difference in CD8+ TEMRa Count Between Week 48 and Week 152	152 weeks
Difference in CD4+ T Cell Count Between Week 0 and Week 48	48 weeks
Difference in CD4+ TEMRo Count Between Week 48 and Week 152	152 weeks
Difference in CD4+ TEMRa Count Between Week 0 and Week 48	48 weeks
Difference in CD8+ TEMRo Count Between Week 48 and Week 152	152 weeks
Difference in CD4+ TCM Count Between Week 48 and Week 152	152 weeks
Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48	48 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48	48 weeks
Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8+ TCM Count Between Week 48 and Week 152	152 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152	152 weeks
Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48	48 weeks
Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152	152 weeks
Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48	48 weeks

Trial Locations

Locations (23): Children's Hopsital of Los Angeles
🇺🇸
Los Angeles, California, United States
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, District of Columbia, United States
Howard University - IMPAACT Site
🇺🇸
Washington, 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
Scroll for more (13 remaining)
Children's Hopsital of Los Angeles
🇺🇸Los Angeles, California, United States