A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
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To determine the safety and tolerance of low-dose versus high-dose cysteamine administered concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune function and viral load in patients receiving these drug regimens.
Condition or disease
Drug: CysteamineDrug: Zidovudine
Patients receive high or low doses of cysteamine plus AZT or placebo plus AZT. The target dose of cysteamine is determined by titration of the dose over a 6-week period, after which the patient receives 24 additional weeks of treatment. An initial cohort of 36 patients will be enrolled in a 10-week pilot phase. Accrual will be temporarily suspended while data from the pilot phase is assessed.
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Ages Eligible for Study:
13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator.
Recombinant erythropoietin and G-CSF if clinically indicated.
Patients must have:
Documented HIV infection.
CD4 count 300 - 500 cells/mm3.
Prior AZT therapy for at least 3 months but less than 12 months prior to study entry.
No past or current AIDS-defining opportunistic infection.
Patients with the following symptoms or conditions are excluded:
Kaposi's sarcoma requiring systemic therapy.
Active malignancy other than basal cell carcinoma or in situ cervical carcinoma.
Antiretroviral therapy other than AZT.
Investigational HIV drugs/therapies other than study drug.
Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine.
Patients with the following prior condition are excluded:
History of treatment-limiting intolerance to 500-600 mg AZT daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity.
Prior antiretroviral therapy other than AZT.
AZT for at least 3 months but no more than 12 months prior to study entry.