Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000733
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus HIV - Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus HIV - Infected Patients
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 how fast ribavirin reaches the bloodstream what concentration of ribavirin is reached in blood and how long it remains in the blood pharmacokinetics when given by different routes of administration To find the maximum tolerated dose MTD of ribavirin The effects of ribavirin on the immune system and on the virus will be measured by T4 cell count and p24 antigen levels
Early studies with ribavirin in patients with AIDS and AIDS related complex ARC have shown that ribavirin appears to inhibit the spread of the virus Determination of how much and how often to give the drug will require further knowledge of the pharmacokinetics and toxicity of the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms
Early studies with ribavirin in patients with AIDS and AIDS related complex ARC have shown that ribavirin appears to inhibit the spread of the virus Determination of how much and how often to give the drug will require further knowledge of the pharmacokinetics and toxicity of the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms
Detailed Description:
Early studies with ribavirin in patients with AIDS and AIDS related complex ARC have shown that ribavirin appears to inhibit the spread of the virus Determination of how much and how often to give the drug will require further knowledge of the pharmacokinetics and toxicity of the drug in patients with AIDS or ARC and in chronic virus carriers who do not have symptoms
Ribavirin is given to HIV-infected patients intravenously as a timed 30-min infusion at 1 of 5 single doses 2 weeks later the same doses are given orally in a single dose Following at least 2 additional weeks 6 patients are then given ribavirin at the lowest dose twice a day for 16 weeks They are evaluated for tolerance and the next group is given a higher dose Each successive group begins at 3-week intervals to receive doses that increase each day until the MTD is reached Blood samples taken periodically during the treatment period and for 8 weeks after treatment is stopped are used to measure blood levels of ribavirin and to determine the effects of ribavirin on the HIV and immune system of the patients
Ribavirin is given to HIV-infected patients intravenously as a timed 30-min infusion at 1 of 5 single doses 2 weeks later the same doses are given orally in a single dose Following at least 2 additional weeks 6 patients are then given ribavirin at the lowest dose twice a day for 16 weeks They are evaluated for tolerance and the next group is given a higher dose Each successive group begins at 3-week intervals to receive doses that increase each day until the MTD is reached Blood samples taken periodically during the treatment period and for 8 weeks after treatment is stopped are used to measure blood levels of ribavirin and to determine the effects of ribavirin on the HIV and immune system of the patients
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 |
|---|---|---|---|
| 11011 | REGISTRY | DAIDS ES Registry Number | None |