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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Free Radical Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002114
  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 II

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Study ID Numbers: 215A, CN9202D
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002114     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

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

ClinicalTrials.gov processed this record on September 02, 2009