A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
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.
Trial Officials
S Pahwa
Study Chair
SS Bakshi
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oakland, California, United States
San Diego, California, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
New York, New York, United States
Rochester, New York, United States
Los Angeles, California, United States
San Francisco, California, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
New Brunswick, New Jersey, United States
Bronx, New York, United States
Brooklyn, New York, United States
Great Neck, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Long Beach, California, United States
Los Angeles, California, United States
Torrance, California, United States
Washington, District Of Columbia, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Paterson, New Jersey, United States
New York, New York, United States
Syracuse, New York, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Seattle, Washington, United States
San Francisco, California, United States
Farmington, Connecticut, United States
New Haven, Connecticut, United States
Albany, New York, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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