A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
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
2 other identifiers
interventional
180
2 countries
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
April 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +4 more criteria
You may not qualify if:
- 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:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801, United States
Usc La Nichd Crs
Los Angeles, California, 90033, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 94609, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 92093, United States
San Francisco Gen. Hosp.
San Francisco, California, 94110, United States
UCSF Pediatric AIDS CRS
San Francisco, California, 94143, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 90502, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, 06032, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06504, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, 30306, United States
Cook County Hosp.
Chicago, Illinois, 60612, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, 60612, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60637, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01655, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, 12208, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, 11021, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, 11040, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016, United States
Metropolitan Hosp. NICHD CRS
New York, New York, 10029, United States
Columbia IMPAACT CRS
New York, New York, 10032, United States
Incarnation Children's Ctr.
New York, New York, 10032, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
DUMC Ped. CRS
Durham, North Carolina, 27710, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 19134, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, 29425, United States
UW School of Medicine - CHRMC
Seattle, Washington, 98105, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, 00956, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00936, Puerto Rico
Related Publications (2)
Bakshi SS, Britto P, Capparelli E, Mofenson L, Fowler MG, Rasheed S, Schoenfeld D, Zimmer B, Frank Y, Yogev R, Jimenez E, Salgo M, Boone G, Pahwa SG. Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection. AIDS Clinical Trials Group Protocol 190 Team. J Infect Dis. 1997 May;175(5):1039-50. doi: 10.1086/520351.
PMID: 9129064BACKGROUNDPerrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
PMID: 21037891BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
S Pahwa
- STUDY CHAIR
SS Bakshi