A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001032
First received: November 2, 1999
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children.

SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria.

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Zalcitabine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection

Resource links provided by NLM:


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

Estimated Enrollment: 180
Study Completion Date: April 1995
Detailed Description:

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Recommended:

  • PCP prophylaxis.

Allowed:

  • Intravenous and/or intramuscular immunoglobulin.
  • Acyclovir (no more than 30 mg/kg/day PO).
  • Ketoconazole (no more than 10 mg/kg/day).
  • Nystatin.
  • Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours.
  • Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy.
  • Trimethoprim / sulfamethoxazole.
  • Amphotericin B (no more than 1 mg/kg for 5 days/week).
  • Aerosolized ribavirin for bronchiolitis.
  • Hematopoietic agents.
  • Other drugs with little nephro-, hepato-, or cytotoxicity.
  • Nutritional support for HIV wasting syndrome or malnutrition.

Patients must have:

  • HIV infection.
  • Ongoing stable AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols.
  • Known allergy or sensitivity to ddC.
  • Cardiomyopathy.

Concurrent Medication:

Excluded:

  • Biologic modifiers other than IVIG, steroids, or hematopoietic agents.
  • Investigational medications unless approved by protocol chair.
  • Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given).

Patients with the following prior conditions are excluded:

  • History of intolerance or toxicity to AZT.
  • History of symptomatic pancreatitis.
  • History of peripheral neuropathy or abnormal nerve conduction velocity test.

Prior Medication:

Excluded:

  • Antiretroviral agents other than AZT within 2 weeks of study entry.

Required:

  • Ongoing stable AZT therapy for more than 6 weeks duration.
  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: NCT00001032

  Hide Study Locations
Locations
United States, California
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Usc La Nichd Crs
Los Angeles, California, United States, 90033
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 92093
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 94143
San Francisco Gen. Hosp.
San Francisco, California, United States, 94110
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90502
United States, Connecticut
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States, 06032
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Howard Univ. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20060
Children's National Med. Ctr., ACTU
Washington, District of Columbia, United States, 20010
United States, Florida
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
United States, Georgia
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States, 30306
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 60614
Cook County Hosp.
Chicago, Illinois, United States, 60612
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States, 60612
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60637
United States, Louisiana
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
United States, New Jersey
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
United States, New York
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, United States, 12208
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States, 11021
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States, 10016
Columbia IMPAACT CRS
New York, New York, United States, 10032
Metropolitan Hosp. NICHD CRS
New York, New York, United States, 10029
Incarnation Children's Ctr.
New York, New York, United States, 10032
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
United States, North Carolina
DUMC Ped. CRS
Durham, North Carolina, United States, 27710
United States, Pennsylvania
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
United States, South Carolina
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 29425
United States, Washington
UW School of Medicine - CHRMC
Seattle, Washington, United States, 98105
Puerto Rico
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamon, Puerto Rico, 00956
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Study Chair: S Pahwa
Study Chair: SS Bakshi
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001032     History of Changes
Other Study ID Numbers: ACTG 190, 11165
Study First Received: November 2, 1999
Last Updated: March 29, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 18, 2014