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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Cysteamine
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cysteamine|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Cysteamine