Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000699
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
1999-11-02
Brief Title:
A Phase III Trial of Ribavirin With Escalation Isoprinosine in Asymptomatic HIV-Viremic Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Trial of Ribavirin With Escalation Isoprinosine in Asymptomatic HIV-Viremic Patients
Status:
COMPLETED
Status Verified Date:
2003-04
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 determine the safety and effectiveness of treatment with ribavirin RBV plus isoprinosine INPX in preventing the development of AIDS in patients infected with the AIDS virus HIV Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when RBV is given with INPX The patients may or may not have generalized lymphadenopathy syndrome LAS RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV The immune system fights infections in the human body and the HIV attacks T cells that are an important part of the immune system Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients but there is no reliable information on the safety and effectiveness of this drug combination in such patients
Detailed Description:
RBV has prevented the development of AIDS in some HIV-infected patients with LAS and INPX has stimulated the immune system of patients infected with HIV The immune system fights infections in the human body and the HIV attacks T cells that are an important part of the immune system Reports from individual cases treated with both RBV and INPX suggest that clinical improvements occurred in HIV-infected patients but there is no reliable information on the safety and effectiveness of this drug combination in such patients
All patients take INPX capsules 4 times a day and RBV capsules 2 or 3 times a day The first group of patients take the dose of RBV shown to be effective in an earlier trial and subsequent groups take higher doses until toxic effects occur The planned treatment period is 3 months but further treatment may be allowed for patients showing improvement Blood samples are taken from an arm vein and used to evaluate possible changes in the patients immune system any toxic effects that might be detected in the blood and possible changes in the presence of HIV in the blood
All patients take INPX capsules 4 times a day and RBV capsules 2 or 3 times a day The first group of patients take the dose of RBV shown to be effective in an earlier trial and subsequent groups take higher doses until toxic effects occur The planned treatment period is 3 months but further treatment may be allowed for patients showing improvement Blood samples are taken from an arm vein and used to evaluate possible changes in the patients immune system any toxic effects that might be detected in the blood and possible changes in the presence of HIV in the blood
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?: