Clinical Trials


The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: February 25, 2000
Last updated: October 4, 2013
Last Verified: October 2013
History of Changes


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.

Condition Intervention
HIV Infections

Biological : Tetanus toxoid
Biological : Hepatitis A Vaccine (Inactivated)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Highly Active Antiretroviral Therapy (HAART) on the Recovery of Immune Function in HIV-Infected Children and Young Adults

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • A stimulation index of 3 or greater on at least 2 occasions to tetanus
  • positive serologic response to hepatitis A
  • four-fold increase over baseline in antibody titers for tetanus
Secondary Outcome Measures:
  • A stimulation index of 3 or greater on at least 2 occasions to hepatitis A and Candida
  • 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

Enrollment: 81
Study Start Date: February 2000
Study Completion Date: September 2006

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.



Ages Eligible for Study: 2 Years to 24 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria

  • HIV infected
  • CD4 percentage less than 15%
  • Beginning an anti-HIV drug regimen (HAART) that includes at least 3 drugs. Two of the drugs must be new to the patient. One of the new drugs must be a protease inhibitor or a nonnucleoside reverse transcriptase inhibitor (NNRTI). As of May 2005, patients who have previously taken NNRTIs will have the option of taking Fuzeon as an alternative component of their HAART regimen
  • Consent of parent or legal guardian
  • As of May 2005, females who become pregnant during the study can continue to participate as long as they become pregnant after receiving all vaccinations

  • Exclusion Criteria
  • Active opportunistic (AIDS-related) or bacterial infection
  • Cancer
  • Immunity to hepatitis A
  • Severe drug toxicity
  • Previous severe or allergic reaction to tetanus vaccine
  • Taking IVIG, IL-2, or other drugs which affect the immune system
  • Taking hydroxyurea
  • Pregnancy at screening visit
  • Pregnancy before all vaccinations have been administered

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004735


United States, Alabama
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
United States, California
Usc La Nichd Crs
Alhambra, California, United States, 91803
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
San Francisco, California, United States, 94143
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80218
United States, District of Columbia
Children's National Med. Ctr., ACTU
Washington, District of Columbia, United States, 20010
Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20060
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33316
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, United States, 32610
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
Tampa, Florida, United States, 33606
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 21287
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01605
United States, New York
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
Nyu Ny Nichd Crs
New York, New York, United States, 10016
New York, New York, United States, 10032
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States, 14642
Stony Brook, New York, United States, 11794
United States, Washington
UW School of Medicine - CHRMC
Seattle, Washington, United States, 98105
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00936

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Study Chair: William Borkowsky, MD NYU Langone Health
Study Chair: Mona Rigaud, MD, MPH NYU Langone Health
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00004735   History of Changes  
Other Study ID Numbers: PACTG P1006  
Study First Received: February 25, 2000  
Last Updated: October 4, 2013  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Viral Vaccines
Drug Therapy, Combination
CD4-Positive T-Lymphocytes
Immunologic Memory
Antibody Formation
Anti-HIV Agents
Tetanus Toxoid
Hepatitis A Virus, Human
Treatment Naive
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections processed this data on July 08, 2020
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