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A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000701
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body.

The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

Resource links provided by NLM:


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

Estimated Enrollment: 12
Study Completion Date: February 1990
Detailed Description:

The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.

Patients are hospitalized for 8 weeks to receive AZT through the intravenous (IV) route at 1 of 2 doses. Patients are then discharged from hospital and take AZT by mouth for 4 more weeks.

  Eligibility

Ages Eligible for Study:   3 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Treatment:

Allowed:

  • Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements).

Exclusion Criteria

Co-existing Condition:

Children with the following conditions are excluded:

  • Asymptomatic with T-lymphocyte deficiency.
  • Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS.
  • Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study.
  • Hemoglobinopathy including sickle cell anemia.
  • Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth.

Children with the following conditions are excluded:

  • Asymptomatic with T-lymphocyte deficiency.
  • Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS.
  • Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study.
  • Hemoglobinopathy including sickle cell anemia.
  • Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth.

Prior Medication:

Excluded:

  • Suramin.
  • Ribavirin.
  • HPA 23.
  • Phosphonoformate.
  • Ansamycin.
  • Interleukin 2.
  • Interferon.
  • Excluded within 30 days of study entry:
  • All cytolytic chemotherapeutic agents, immunomodulating agents including steroids and immunoglobulin preparations.
  • Antivirals (acyclovir, ganciclovir).

Prior Treatment:

Excluded within 4 weeks of study entry:

  • Lymphocyte transfusions for immune reconstitution.
  • Excluded within 3 months of study entry:
  • Bone marrow transplant.

Child who is seropositive for HIV antibody or has HIV viremia and presents with one or more of following clinical criteria and at least one of the laboratory criteria may be considered an ARC patient for purpose of study:

  • Clinical criteria:
  • Persistent oral candidiasis despite appropriate therapy.
  • Wasting syndrome characterized by failure to thrive and malnutrition.
  • Recurrent or chronic unexplained diarrhea.
  • Lymphadenopathy (more than 1 cm) at 2 or more noncontiguous sites.
  • Hepatomegaly with or without splenomegaly.
  • Encephalopathy with loss of developmental milestones and cortical atrophy present on computed tomography (CT) examination.
  • Recurrent bacterial infections (bacteremia, pneumonia, septic arthritis, meningitis).
  • Cutaneous anergy as defined by lack of delayed cutaneous hypersensitivity to selected antigens.
  • Laboratory criteria:
  • Hypergammaglobulinemia (IgG or IgA) defined as immunoglobulin values exceeding the maximum age-adjusted level.
  • Decreased number of total T-lymphocytes (2 SD from mean).
  • Absolute depression in T-helper cells to less than 500/mm3.
  • Depressed (equal to or more than 2 SD from normal mean) in vitro mitogen response to at least one antigen.
  • One positive HIV culture within 3 months of study entry into the study or blood obtained and culture pending.
  • Life expectancy greater than 6 months.
  • Ambulatory and free of opportunistic infection at time of entry.
  • Reliably diagnosed disease at least moderately indicative of underlying cellular immunodeficiency and no known cause of underlying cellular immunodeficiency or other reduced resistance reported to be associated with that disease.
  • Disease accepted as sufficiently indicative of underlying cellular immunodeficiency by CDC. In absence of these opportunistic diseases, a histologically confirmed diagnosis of chronic lymphoid interstitial pneumonitis will be considered indicative of AIDS unless test(s) for HIV are negative.
  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: NCT00000701

Locations
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Investigators
Study Chair: Scott G
Study Chair: Wilfert C
Study Chair: Pizzo P
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000701     History of Changes
Other Study ID Numbers: ACTG 003, Protocol 26,541-004, Project p53, 10979
Study First Received: November 2, 1999
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
AIDS-Related Complex
Acquired Immunodeficiency Syndrome
HIV Infections
Syndrome
Disease
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014