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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Infectious Disease Research Institute Inc
Tampa, Florida, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, United States
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Independent Research Nurses Inc
Cranston, Rhode Island, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States