Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000844
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Multicenter Prospective Randomized Double-Blind Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4 Counts 50 and 350 Cellsmm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Prospective Randomized Double-Blind Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4 Counts 50 and 350 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2021-10
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 evaluate the effects of three preparations of low-dose oral interferon alpha ie Alferon LDO Veldona and Ferimmune on HIV symptoms in HIV-infected patients To evaluate differences in response to oral interferon alpha according to gender raceethnicity and use of antiretrovirals
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design Therefore three preparations will be compared to evaluate their potential efficacies
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design Therefore three preparations will be compared to evaluate their potential efficacies
Detailed Description:
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design Therefore three preparations will be compared to evaluate their potential efficacies
Patients are randomized to receive 6 months of Alferon LDO alone Alferon with Veldona Alferon with Ferimmune or three placebos with follow-up visits monthly
Patients are randomized to receive 6 months of Alferon LDO alone Alferon with Veldona Alferon with Ferimmune or three placebos with follow-up visits monthly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11727 | REGISTRY | DAIDS ES Registry Number | None |