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

October 4, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

The Effects of Highly Active Antiretroviral Therapy (HAART) on the Recovery of Immune Function in HIV-Infected Children and Young Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

February 25, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 4, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACTG P1006
  • 10036 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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