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A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
This study has been completed.
First Received: November 2, 1999   Last Updated: August 18, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001032
  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 II

Study Type: Interventional
Study Design: 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001032

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States, 35294
United States, California
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Stanford Univ School of Medicine / Pediatrics
Stanford, California, United States, 943054149
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
San Francisco Gen Hosp
San Francisco, California, United States, 94110
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States, 900481804
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Univ of Connecticut / Farmington
Farmington, Connecticut, United States, 06032
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
Children's Hosp of Washington DC
Washington, District of Columbia, United States, 200102916
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
United States, Illinois
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States, 11203
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Westchester Hosp
Valhalla, New York, United States, 10595
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Mount Sinai Med Ctr
New York, New York, United States, 10029
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Lincoln Hosp Ctr
Bronx, New York, United States, 10451
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, United States, 14222
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
United States, Ohio
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, Pennsylvania
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
United States, Rhode Island
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, United States, 02903
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Canada, Ontario
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, Puerto Rico, 00956
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Sponsors and Collaborators
Investigators
Study Chair: S Pahwa
Study Chair: SS Bakshi
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 190
Study First Received: November 2, 1999
Last Updated: August 18, 2008
ClinicalTrials.gov Identifier: NCT00001032     History of Changes
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:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Zalcitabine
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009