A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
2 other identifiers
interventional
140
2 countries
35
Brief Summary
To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy. As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
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
35 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
June 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 27, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Procrit.
- Amphotericin B (1 mg/kg up to 5 days/week).
- Prophylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia.
- Acyclovir (up to 1000 mg/day PO; for \> 1000 mg/day PO or for any IV dose, suggest interrupting ddC).
- Ketoconazole (up to 10 mg/kg/day).
- Nystatin.
- Aspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours).
- Isoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25
- mg/day to avoid possible INH-associated neuropathy.
- Trimethoprim / sulfamethoxazole (T/S).
- Immunoglobulin therapy.
- Aerosolized pentamidine.
- Drugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition.
- +23 more criteria
You may not qualify if:
- Co-existing Condition:
- AMENDED:
- Additional excluded symptoms and conditions:
- Symptomatic cardiomyopathy.
- Seizures which are not well controlled by ongoing anticonvulsant therapy.
- Active malignancy requiring concomitant chemotherapy.
- Symptomatic pancreatitis.
- Grade I or greater peripheral neuropathy.
- Receiving concomitant zidovudine (AZT).
- Patients with the following conditions or symptoms are excluded:
- Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
- Known hypersensitivity to dideoxycytidine (ddC).
- Concurrent Medication:
- Excluded:
- Other antiviral agents, biological modifiers, and investigational medications.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 90095, 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
UCSF Pediatric AIDS CRS
San Francisco, California, 94143, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, 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, 30303, 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
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 21287, 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
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, 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, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, 11042, 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
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10456, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, 27599, United States
DUMC Ped. CRS
Durham, North Carolina, 27710, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 19134, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, 00619, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00936, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
Related Publications (2)
Perrier 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: 21037891BACKGROUNDSpector SA, Blanchard S, Connor EM, Salgo MP, McNamara J. Results of a clinical trial comparing two doses of 2'3'-dideoxycytidine (ddC) in the treatment of children with symptomatic human immunodeficiency virus (HIV) infection who were intolerant or had failed zidovudine (ZDV) therapy (ACTG 138). The Pediatric AIDS Clinical Trials Group. American Pediatric Society 104th annual meeting and Society for Pediatric Research 63rd annual meeting; 1994 May 2-5; Seattle. Pediatr AIDS HIV Infect. 1994 Oct;5(5):323 (unnumbered abstract)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Spector SA