A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
2 other identifiers
interventional
300
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
October 1, 1995
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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:
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1995-10