Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001015
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses
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 determine the maximum long-term dosage of ribavirin RBV that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses Also to determine what effect different dosage levels have on biologic markers of efficacy such as the amount of the AIDS virus HIV or number of T cells in the patients blood
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells In earlier tests of RBV in AIDS patients the drug was well tolerated and safe and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex ARC
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells In earlier tests of RBV in AIDS patients the drug was well tolerated and safe and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex ARC
Detailed Description:
RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells In earlier tests of RBV in AIDS patients the drug was well tolerated and safe and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex ARC
Patients are selected from three patient groups
Patients with AIDS who have not taken zidovudine AZT within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance
Patients with AIDS related diseases who have not taken AZT within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance
Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy This is an outpatient study patients are seen weekly for the first 4 weeks every other week through week 12 and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study Patients from each of the three diagnostic groups are enrolled at each dose level For the first 3 days after entry into the study all patients receive the lowest dose of RBV every 6 hours Subsequent dosages increase until the maximum tolerated dose MTD is reached The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage
Patients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance
Patients are selected from three patient groups
Patients with AIDS who have not taken zidovudine AZT within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance
Patients with AIDS related diseases who have not taken AZT within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance
Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy This is an outpatient study patients are seen weekly for the first 4 weeks every other week through week 12 and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study Patients from each of the three diagnostic groups are enrolled at each dose level For the first 3 days after entry into the study all patients receive the lowest dose of RBV every 6 hours Subsequent dosages increase until the maximum tolerated dose MTD is reached The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage
Patients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance
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 |
|---|---|---|---|
| 11010 | REGISTRY | DAIDS ES Registry Number | None |