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

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00004735

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)

MedlinePlus related topics: AIDS AIDS Medicines Hepatitis Hepatitis A Tetanus

Drug Information available for: Tetanus Vaccine Hepatitis A Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Estimated Enrollment:

90

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004735

Show 53 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

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

Investigators

Study Chair:	William Borkowsky, MD	New York University Medical Center
Study Chair:	Mona Rigaud, MD, MPH	New York University Medical Center

More Information

Additional Information:

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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 immunocompromised children and adolescents during the first year of effective highly active antiretroviral therapy. J Infect Dis. 2008 Oct 15;198(8):1123-30.

Study ID Numbers:	PACTG P1006
Study First Received:	February 25, 2000
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00004735 History of Changes
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

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Tetanus
Immunologic Deficiency Syndromes
Enfuvirtide
Hepatitis

Virus Diseases
Antibodies
HIV Infections
Sexually Transmitted Diseases
Hepatitis A
Retroviridae Infections
Immunoglobulins

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009