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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00004735
First received: February 25, 2000
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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.

  Eligibility

Ages Eligible for Study:   2 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier: NCT00004735

  Show 27 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: William Borkowsky, MD New York University School of Medicine
Study Chair: Mona Rigaud, MD, MPH New York University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00004735     History of Changes
Other Study ID Numbers: PACTG P1006, 10036
Study First Received: February 25, 2000
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

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
Enfuvirtide
T-20
Treatment Naive
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014