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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000653

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

140

Expected to finish

1995-06-01

Last updated by the study team

2021-10-27

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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
• 50 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.
• Concurrent Treatment:
• Allowed:
• Immunoglobulin therapy.
• Nutritional support (for children with wasting syndrome and/or malnutritional) including hyperalimentation (TPN) of dietary supplements.
• AMENDED:
• Patients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study.
• ORIGINAL design:
• Patients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol.
• Patients must have the following:
• Absence of acute opportunistic infection at time of entry.

You may not qualify if…

• Co-existing Condition:
• AMENDED:
• 04-25-91 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.
• Drugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin.
• Patients with the following are excluded:
• Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry.
• Known hypersensitivity to dideoxycytidine (ddC).
• Active opportunistic infection requiring treatment with an excluded concomitant medication.
• Prior Medication:
• Excluded:
• Antiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry.
• Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
• Any other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.

Where it is running

• 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
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Children's National Med. Ctr., ACTU — 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
• 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, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — 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
• UMDNJ - Robert Wood Johnson — New Brunswick, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, 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, United States
• NYU Med. Ctr., Dept. of Medicine — New York, New York, United States
• Metropolitan Hosp. NICHD CRS — New York, New York, United States
• Columbia IMPAACT CRS — New York, New York, United States

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