A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease

NCT ID: NCT00002110

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL

Brief Summary

To determine the safety and tolerance of low-dose versus high-dose cysteamine administered concurrently with zidovudine (AZT). To determine the pharmacokinetics and effects on immune function and viral load in patients receiving these drug regimens.

Detailed Description

Patients receive high or low doses of cysteamine plus AZT or placebo plus AZT. The target dose of cysteamine is determined by titration of the dose over a 6-week period, after which the patient receives 24 additional weeks of treatment. An initial cohort of 36 patients will be enrolled in a 10-week pilot phase. Accrual will be temporarily suspended while data from the pilot phase is assessed.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Cysteamine

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Chemoprophylaxis for Pneumocystis carinii pneumonia, candidiasis, Mycobacterium tuberculosis, and herpes as prescribed by the investigator.
• Recombinant erythropoietin and G-CSF if clinically indicated.

Patients must have:

• Documented HIV infection.
• CD4 count 300 - 500 cells/mm3.
• Prior AZT therapy for at least 3 months but less than 12 months prior to study entry.
• No past or current AIDS-defining opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Kaposi's sarcoma requiring systemic therapy.
• Active malignancy other than basal cell carcinoma or in situ cervical carcinoma.

Concurrent Medication:

Excluded:

• Antiretroviral therapy other than AZT.
• Immunosuppressive drugs.
• Investigational HIV drugs/therapies other than study drug.
• Interferon.
• Steroids.
• Hematopoietins.
• Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine.

Concurrent Treatment:

Excluded:

• Radiation therapy.

Patients with the following prior condition are excluded:

History of treatment-limiting intolerance to 500-600 mg AZT daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity.

Prior Medication:

Excluded:

• Prior antiretroviral therapy other than AZT.

Required:

• AZT for at least 3 months but no more than 12 months prior to study entry.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Laboratories

INDUSTRY

Sponsor Role: lead

Locations

Infectious Disease Research Institute Inc

Tampa, Florida, United States

Tulane Univ Med School

New Orleans, Louisiana, United States

SUNY / Health Sciences Ctr at Stony Brook

Stony Brook, New York, United States

Bowman Gray School of Medicine / North Carolina Baptist Hosp

Winston-Salem, North Carolina, United States

Independent Research Nurses Inc

Cranston, Rhode Island, United States

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

CYST-9304

Identifier Type: -

Identifier Source: secondary_id

211A

Identifier Type: -

Identifier Source: org_study_id