A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001032

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

180

Expected to finish

1995-04-01

Last updated by the study team

2021-11-04

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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.
• Nutritional support for HIV wasting syndrome or malnutrition.
• Patients must have:
• HIV infection.
• Ongoing stable AZT therapy.

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:
• Excluded:
• Antiretroviral agents other than AZT within 2 weeks of study entry.
• Required:
• Ongoing stable AZT therapy for more than 6 weeks duration.

Where it is running

• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Usc La Nichd Crs — Los Angeles, California, 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, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• San Francisco Gen. Hosp. — San Francisco, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Connecticut Health Ctr., Dept. of Ped. — Farmington, Connecticut, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Atlanta, Georgia, United States
• Cook County Hosp. — Chicago, Illinois, United States
• Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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