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NCT00004735 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004735
Other study ID # PACTG P1006
Secondary ID 10036
Status Completed
Phase N/A
First received February 25, 2000
Last updated October 4, 2013
Start date February 2000
Est. completion date September 2006

Study information
Verified date October 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 81
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 24 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Tetanus toxoid

• Hepatitis A Vaccine (Inactivated)

Locations
Country Name City State
Puerto Rico San Juan City Hosp. PR NICHD CRS San Juan
Puerto Rico Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS San Juan
United States Usc La Nichd Crs Alhambra California
United States Univ. of Colorado Denver NICHD CRS Aurora Colorado
United States Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases Baltimore Maryland
United States UAB, Dept. of Ped., Div. of Infectious Diseases Birmingham Alabama
United States BMC, Div. of Ped Infectious Diseases Boston Massachusetts
United States HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts
United States Bronx-Lebanon Hosp. IMPAACT CRS Bronx New York
United States Chicago Children's CRS Chicago Illinois
United States South Florida CDTC Ft Lauderdale NICHD CRS Fort Lauderdale Florida
United States Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy Gainesville Florida
United States Long Beach Memorial Med. Ctr., Miller Children's Hosp. Long Beach California
United States Univ. of Miami Ped. Perinatal HIV/AIDS CRS Miami Florida
United States Schneider Children's Hosp., Div. of Infectious Diseases New Hyde Park New York
United States Tulane/LSU Maternal/Child CRS New Orleans Louisiana
United States Columbia IMPAACT CRS New York New York
United States Harlem Hosp. Ctr. NY NICHD CRS New York New York
United States Nyu Ny Nichd Crs New York New York
United States Strong Memorial Hospital Rochester NY NICHD CRS Rochester New York
United States UCSF Pediatric AIDS CRS San Francisco California
United States UW School of Medicine - CHRMC Seattle Washington
United States SUNY Stony Brook NICHD CRS Stony Brook New York
United States USF - Tampa NICHD CRS Tampa Florida
United States Children's National Med. Ctr., ACTU Washington District of Columbia
United States Howard Univ. Washington DC NICHD CRS Washington District of Columbia
United States WNE Maternal Pediatric Adolescent AIDS CRS Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

Melvin AJ, Mohan KM. Response to immunization with measles, tetanus, and Haemophilus influenzae type b vaccines in children who have human immunodeficiency virus type 1 infection and are treated with highly active antiretroviral therapy. Pediatrics. 2003 Jun;111(6 Pt 1):e641-4. — View Citation

Rigaud M, Borkowsky W, Muresan P, Weinberg A, Larussa P, Fenton T, Read JS, Jean-Philippe P, Fergusson E, Zimmer B, Smith D, Kraimer J; Pediatrics AIDS Clinical Trials Group P1006 Team. Impaired immunity to recall antigens and neoantigens in severely immu — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary A stimulation index of 3 or greater on at least 2 occasions to tetanus
Primary positive serologic response to hepatitis A
Primary four-fold increase over baseline in antibody titers for tetanus
Secondary A stimulation index of 3 or greater on at least 2 occasions to hepatitis A and Candida
Secondary increase in CD4 cell percentage by 10% and absolute CD4 number by 150 cells/ml
Secondary development of any adverse events of Grade 3 or higher attributable to vaccination
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