Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r)
- Conditions
- HIV Infections
- Interventions
- Procedure: Standard CareProcedure: Early Initiation of Highly Active Anti-Retroviral Therapy
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Arm Standard Care 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. Experimental Arm Early Initiation of Highly Active Anti-Retroviral Therapy 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.
- 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 CD8 TEMRo CD38 Percentage Between Week 0 and Week 48 48 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 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 Naïve T-Cell Percentage Expressing HLA-DR 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 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)
Howard University - IMPAACT Site
🇺🇸Washington, District of Columbia, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
Children's Hospital of Denver - IMPAACT Site
🇺🇸Aurora, Colorado, United States
University of Southern Florida College of Medicine
🇺🇸Tampa, Florida, United States
Children's Hospital of Michigan - IMPAACT Site
🇺🇸Detroit, Michigan, United States
St. Jude Children's Research Hospital (Memphis) - IMPAACT Site
🇺🇸Memphis, Tennessee, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University - IMPAACT Site
🇺🇸Baltimore, Maryland, United States
Children's Hopsital of Los Angeles
🇺🇸Los Angeles, California, United States
Stoger Hospital of Cook County
🇺🇸Chicago, Illinois, United States
University of Southern California - IMPAACT Site
🇺🇸Los Angeles, California, United States
Childrens Memorial Hospital
🇺🇸Chicago, Illinois, United States
Children's Diagnostic and Treatment Center
🇺🇸Fort Lauderdale, Florida, United States
UMDNJ - IMPAACT Site
🇺🇸Newark, New Jersey, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Miami
🇺🇸Miami, Florida, United States
Duke Pediatric Infectious Diseases - IMPAACT Site
🇺🇸Durham, North Carolina, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
St. Jude Childrens Research Hospital
🇺🇸Memphis, Tennessee, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States