A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1995
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.
||Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
||A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
| Estimated Enrollment:
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.
|Ages Eligible for Study:
||13 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
- Antiretroviral therapy other than AZT.
- Immunosuppressive drugs.
- Investigational HIV drugs/therapies other than study drug.
- Cytotoxic chemotherapy including Adriamycin, bleomycin, and vincristine.
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 antiretroviral therapy other than AZT.
- AZT for at least 3 months but no more than 12 months prior to study entry.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002110
|Infectious Disease Research Institute Inc
|Tampa, Florida, United States, 33614 |
|Tulane Univ Med School
|New Orleans, Louisiana, United States, 701122699 |
|SUNY / Health Sciences Ctr at Stony Brook
|Stony Brook, New York, United States, 117948153 |
|Bowman Gray School of Medicine / North Carolina Baptist Hosp
|Winston Salem, North Carolina, United States, 271571042 |
|Independent Research Nurses Inc
|Cranston, Rhode Island, United States, 02910 |
|Univ of Texas Southwestern Med Ctr of Dallas
|Dallas, Texas, United States, 75235 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors