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

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.

However, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for \> 4 weeks are eligible.

Parent or guardian available to give written informed consent.

Allowed at time of study entry:

Prophylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP).

Immunoglobulin therapy.

Prior Medication:

AMENDED:

AZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry

Allowed:

Zidovudine (AZT) within 4 weeks of entry.

Dideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI.

Other toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC.

Vitamin, folate, iron supplements.

What this study is about