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| Sponsor: | Mylan Laboratories |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002110 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Cysteamine Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| Official Title: | A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease |
| Estimated Enrollment: | 300 |
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| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
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:
Required:
Contacts and Locations| United States, Florida | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, New York | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| United States, North Carolina | |
| Bowman Gray School of Medicine / North Carolina Baptist Hosp | |
| Winston Salem, North Carolina, United States, 271571042 | |
| United States, Rhode Island | |
| Independent Research Nurses Inc | |
| Cranston, Rhode Island, United States, 02910 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
More Information
| Study ID Numbers: | 211A, CYST-9304 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002110 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination AIDS-Related Complex Zidovudine Cysteamine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Radiation-Protective Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Cysteamine Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Protective Agents Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |