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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002110

Run by

Mylan Laboratories

People needed

300

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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