A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Cysteamine (Drug); Zidovudine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Mylan Laboratories
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.
Clinical Details
Official title: A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
Study design: Treatment, Double-Blind, Pharmacokinetics Study
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States
Tulane Univ Med School, New Orleans, Louisiana 701122699, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp, Winston Salem, North Carolina 271571042, United States
Independent Research Nurses Inc, Cranston, Rhode Island 02910, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Additional Information
Last updated: June 23, 2005
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