Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001035
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Pilot Study of the Safety and Efficacy of Interferon Alfa-2b IFN Alfa-2b in Combination With Nucleoside Analog Therapy in Patients With Combined Hepatitis C HCV and Advanced Human Immunodeficiency Virus HIV Infections
Status:
COMPLETED
Status Verified Date:
2012-04
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 investigate the toxicity of interferon alfa-2b IFN alfa-2b in combination with nucleoside analog therapy in HIV-positive patients with chronic hepatitis C To determine the efficacy of treatment with IFN alfa-2b for chronic hepatitis C in patients with advanced HIV infections treated with nucleoside analog therapy
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C but the drugs benefit against hepatitis C in patients with advanced HIV infection has not been determined
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C but the drugs benefit against hepatitis C in patients with advanced HIV infection has not been determined
Detailed Description:
IFN alfa-2b has HIV inhibitory properties and has also been approved for treatment of chronic hepatitis C Studies have shown that IFN alfa-2b is effective in asymptomatic HIV-positive patients with chronic hepatitis C but the drugs benefit against hepatitis C in patients with advanced HIV infection has not been determined
Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy dose is increased Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months All patients will also receive available nucleoside analog therapy zidovudine didanosine zalcitabine at currently accepted doses as clinically appropriate
Patients receive interferon alpha-2b subcutaneously 3 times weekly for 6 months If no response is seen after 18 weeks of therapy or if an initial response is followed by relapse while on therapy dose is increased Patients who require a dose escalation should continue on IFN alfa-2b for an additional 6 months All patients will also receive available nucleoside analog therapy zidovudine didanosine zalcitabine at currently accepted doses as clinically appropriate
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 |
|---|---|---|---|
| 11180 | REGISTRY | DAIDS ES Registry Number | None |