We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002114
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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).

Condition Intervention Phase
HIV Infections Drug: Procysteine Phase 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized Parallel Group Study Comparing Procysteine to Placebo in HIV-Infected Patients Who Are Taking Antiretroviral Nucleosides

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 125
Estimated Study Completion Date: January 1994
Detailed Description:
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00002114     History of Changes
Other Study ID Numbers: 215A
CN9202D
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: January 1994

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases