a double-blind, randomized parallel group study comparing procysteine to placebo in hiv-infected patients who are taking antiretroviral nucleosides

Conditions: HIV Infections

Summary: to compare the efficacy and safety of orally administered procysteine with placebo in hiv-infected patients who are receiving 1 of the following: (1) zidovudine (azt) alone; (2) didanosine (ddi) alone; (3) azt plus ddi; or (4) azt plus zalcitabine (ddc).

all patients must receive treatment with antiretroviral nucleosides in addition to study treatment. patients are randomized equally into 1 of 3 outpatient dosage groups. group 1 receives placebo; group 2 receives a low dose of procysteine; and group 3 receives a higher dose of procysteine. patients receive study treatment for 6 months (total duration of patient participation is 30 weeks).

Eligibility criteria:
inclusion criteria concurrent medication: required: antiretroviral nucleosides (azt alone, ddi alone, azt plus ddi, or azt plus ddc). regimen may be altered on or after week 16. allowed: * appropriate topical treatment or local radiotherapy for ks. * treatment or prophylaxis for opportunistic infections, including pentamidine, cotrimoxazole, acyclovir, fluconazole, etc., at the discretion of the investigator. patients must have: * documented serologic evidence confirming hiv infection. * ability to participate in an outpatient study for at least 26 weeks. * either: * (a) diagnosis of aids or aids-related complex (arc) with cd4 count of 50 - 300 cells/mm3, or (b) cd4 count of 50 - 200 cells/mm3 and no symptoms of aids (asymptomatic). (note: * patients whose aids-defining condition is kaposi's sarcoma alone must have cd4 count of 50 - 200 cells/mm3.) exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * evidence of organ involvement with cmv and/or positive blood cultures for mycobacterium avium. * life expectancy less than 26 weeks. * malignancy or advancing kaposi's sarcoma (ks) with advancing or unstable skin lesion, or known or suspected visceral disease which requires systemic cytotoxic, myelosuppressive chemotherapy. * stage 2 or greater aids-dementia complex (adc), defined as ability to perform basic activities of self-care but inability to work or maintain more demanding aspects of daily life as a result of an acquired decrease in cognitive cns-related motor function characteristic of adc. * psychological or emotional problems that prevent adequate compliance with study therapy. concurrent medication: excluded: * daily vitamin c dosage greater than 1,000 mg or daily vitamin e dosage greater than 100 units. * n-acetylcysteine, cysteine, or glutathione. * any investigational drug. * systemic chemotherapy. patients with the following prior conditions are excluded: * history of organ involvement with cytomegalovirus (cmv) and/or positive blood cultures for mycobacterium avium. * intractable diarrhea, defined as greater than 4 bowel movements per day for at least 2 weeks. * history of seizures which have not been controlled with appropriate anticonvulsant medications within the previous 6 months. prior medication: excluded: * any investigational agent or biological response modifier (including interferon or corticosteroids) within 1 month of study entry. * use of erythropoietin (epo), g-csf, or gm-csf within 28 days of randomization. risk behavior: excluded: active alcohol or drug abuse. required: antiretroviral nucleosides (azt alone, ddi alone, azt plus ddi, or azt plus ddc) for at least 3 months prior to study entry.