The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV
- Conditions
- HIV Infections
- Registration Number
- NCT00004735
- Brief Summary
The purpose of this study is to determine the number of newly formed CD4 cells in children who have taken anti-HIV drugs. The study will also evaluate the effectiveness of the new CD4 cells in producing an immune response to hepatitis A and tetanus toxoid vaccination.
Study hypothesis: 1) Immunologic reconstitution of individuals who have less than 15% CD4 cells may or may not be associated with functional activity. 2) The functional immunologic responses to recall and newly experienced antigens may be different. 3) The functional responses to antigens delivered in vaccine format may be a function of CD4 level, viral load, or both.
- Detailed Description
HIV damages the immune system by infecting CD4 cells, white blood cells that help fight infections and protect the body from disease. As CD4 cells die, the immune system becomes weak. Taking anti-HIV drugs slows the ability of the virus to multiply and kill CD4 cells. HIV infected children taking anti-HIV drugs have significant inhibition of HIV growth and significant increases in CD4 cell counts. It is not known to what extent CD4 count increases in HIV infected children translate to functional immune recovery. HIV infected children have typically demonstrated poor serological responses to routine childhood immunizations.
Participants will either begin HAART or make a change to their current HAART regimens at study entry or within 2 weeks prior to study entry. All participants will have viral load testing when they begin or change their HAART regimens. Participants will then have a second viral load test after 4 weeks. Only participants with an acceptable decrease in viral load will continue in the study.
Participants will be randomly assigned to one of two groups. Participants in Group 1 will receive tetanus toxoid immunizations (known as DTaP, DT-pediatric, or Td) at Weeks 8, 16, and 24 and hepatitis A vaccinations at Weeks 32, 40, and 48. Participants in Group 2 will receive hepatitis A vaccinations at Weeks 8, 16, and 24 and tetanus toxoid immunizations at Weeks 32, 40, and 48. Participants will have a physical exam and blood tests at study entry and at Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 48, 52, 76, and 100.
As of May 2005, participants will have the option to receive an additional hepatitis A vaccination booster. Those who consent and have not reached Week 100 of the study will receive a booster vaccination at Week 100, with a final follow-up visit occuring at Week 104. Those participants who do not consent will not receive the hepatitis A vaccination booster and will have their last follow-up visit at Week 100.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method positive serologic response to hepatitis A A stimulation index of 3 or greater on at least 2 occasions to tetanus four-fold increase over baseline in antibody titers for tetanus
- Secondary Outcome Measures
Name Time Method increase in CD4 cell percentage by 10% and absolute CD4 number by 150 cells/ml development of any adverse events of Grade 3 or higher attributable to vaccination A stimulation index of 3 or greater on at least 2 occasions to hepatitis A and Candida
Trial Locations
- Locations (27)
South Florida CDTC Ft Lauderdale NICHD CRS
🇺🇸Fort Lauderdale, Florida, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
Usc La Nichd Crs
🇺🇸Alhambra, California, United States
UAB, Dept. of Ped., Div. of Infectious Diseases
🇺🇸Birmingham, Alabama, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Schneider Children's Hosp., Div. of Infectious Diseases
🇺🇸New Hyde Park, New York, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
USF - Tampa NICHD CRS
🇺🇸Tampa, Florida, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Harlem Hosp. Ctr. NY NICHD CRS
🇺🇸New York, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
🇺🇸Gainesville, Florida, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
Nyu Ny Nichd Crs
🇺🇸New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
🇺🇸Rochester, New York, United States