A Double-Blind, Randomized Parallel Group Study Comparing Procysteine to Placebo in HIV-Infected Patients Who Are Taking Antiretroviral Nucleosides
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1994
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).
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||A Double-Blind, Randomized Parallel Group Study Comparing Procysteine to Placebo in HIV-Infected Patients Who Are Taking Antiretroviral Nucleosides
| Estimated Enrollment:
| Estimated Study Completion Date:
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).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Antiretroviral nucleosides (AZT alone, ddI alone, AZT plus ddI, or AZT plus ddC). Regimen may be altered on or after Week 16.
- 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.
- (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.)
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.
- 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.
- 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.
Active alcohol or drug abuse.
Antiretroviral nucleosides (AZT alone, ddI alone, AZT plus ddI, or AZT plus ddC) for at least 3 months prior to study entry.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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No publications provided
ClinicalTrials.gov processed this record on October 09, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration