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

NCT00002114 | Completed Phase 2

• 2 other identifiers: 215ACN9202D
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

HIV Infections

Interventions

Procysteine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Free Radical Sciences: lead

MeSH Terms

Conditions

HIV Infections

Interventions

2-oxothiazolidine-4-carboxylic acid

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: January 1, 1994
• Last Updated: June 24, 2005

Record last verified: 1994-01