Status:
COMPLETED
A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
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...
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 pos...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1995
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00001032
End Date
April 1 1995
Last Update
November 4 2021
Active Locations (47)
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1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609