Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002099
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase IIIII Study of the Tolerance and Efficacy of Combined Use of Didanosine 23-Dideoxyinosine ddI and Lentinan in HIV-Positive Patients
Sponsor:
AJI Pharma USA
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase IIIII Study of the Tolerance and Efficacy of Combined Use of Didanosine 23-Dideoxyinosine ddI and Lentinan in HIV-Positive Patients
Status:
UNKNOWN
Status Verified Date:
1994-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 tolerance and side effects of a combination of lentinan and didanosine ddI in comparison with ddI alone To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period 6-12 months as measured by an increase in one or more of the following neutrophil count and activity T-cell subsets and a decrease in p24 antigen
Detailed Description:
Patients are treated with daily oral ddI for 6 weeks then are randomized to ddI in combination with intravenous lentinan or placebo administered once weekly for 26 weeks Patients who are already stabilized on 400 mgday ddI will proceed directly to randomization Following completion of the combination therapy patients may be offered 26 additional weeks of therapy on an optional basis
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 |
|---|---|---|---|
| 92-11-9 | None | None | None |