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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Procysteine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Free Radical Sciences

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).

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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