Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002110
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase IIIII Study of Cysteamine Mercaptoethylamine and Zidovudine for the Treatment of HIV Disease
Sponsor:
Mylan Laboratories
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IIIII Study of Cysteamine Mercaptoethylamine and Zidovudine for the Treatment of HIV Disease
Status:
COMPLETED
Status Verified Date:
1995-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CYST-9304 | None | None | None |