A Double-Blind, Randomized Parallel Group Study Comparing Procysteine to Placebo in HIV-Infected Patients Who Are Taking Antiretroviral Nucleosides

• Status: Completed
• Trial end date: 1994-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Free Radical Sciences

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.