Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002098
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase III 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 III Study of the Tolerance and Efficacy of Combined Use of Didanosine 23-Dideoxyinosine ddI and Lentinan in HIV-Positive Patients
Status:
COMPLETED
Status Verified Date:
1995-03
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 tolerance and side effects of a combination of lentinan and didanosine ddI compared 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 randomized to receive either lentinan 40 patients or placebo 10 patients in combination with ddI for at least 26 weeks those tolerating their dose may be offered continuation of therapy for an additional 26 weeks
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 |
|---|---|---|---|
| 91-10-15 | None | None | None |