A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic… (NCT00000653) | Clinical Trial Compass
CompletedPhase 2
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
United States140 participants
Plain-language 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.
Who can participate
Age range3 Months – 18 Years
SexALL
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Inclusion Criteria
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 infe…
Trial details
NCT IDNCT00000653
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)