Overview
A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mylan LaboratoriesTreatments:
Cysteamine
Zidovudine
Criteria
Inclusion CriteriaConcurrent 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.