Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001074
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in 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:
A Phase III Dosing Study of the Safety and Antiretroviral Activity of Hydroxyurea Alone and in Combination With ddI Compared With ddI Alone in Subjects With HIV Infection
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 safety and tolerability of hydroxyurea at two doses alone and in combination with didanosine ddI To compare the short term antiviral effect of ddI monotherapy versus hydroxyurea plus ddI as measured by plasma RNA levels at 8 weeks of therapy AS PER AMENDMENT 10197 Accrual to arms involving hydroxyurea alone has been closed Current antiviral therapies for HIV-1 are limited by a few choices and the lack of sustained clinical benefit from the drugs The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription Based on this information comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI with the cellular enzyme ribonucleotide reductase as a potential target should be done
Detailed Description:
Current antiviral therapies for HIV-1 are limited by a few choices and the lack of sustained clinical benefit from the drugs The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription Based on this information comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI with the cellular enzyme ribonucleotide reductase as a potential target should be done
This is a 24-week study with two 12-week treatment periods Patients are randomized to one of five treatment arms based upon a patients history of antiretroviral therapy naive vs experienced The five treatment arms are
1 ddI plus hydroxyurea placebo
2 hydroxyurea lower dose plus ddI placebo for 4 weeks then hydroxyurea higher dose plus ddI
3 hydroxyurea higher dose plus ddI placebo for 4 weeks then hydroxyurea higher dose plus ddI
4 hydroxyurea lower dose plus ddI
5 hydroxyurea higher dose plus ddI After the completion of week 12 patients on combination therapy remain on their current therapy and patients on ddI plus placebo have hydroxyurea replace the placebo at 1 of 2 assigned doses 11 randomization AS PER AMENDMENT 5597 If after the 24-week treatment period a patient has an RNA level less than or equal to 5000 copiesml or less than 20000 copiesml with a greater than 1 log10 decline from baseline she has the option to continue therapy open-label ddI plus hydroxyurea for an additional 24 weeks
AS PER AMENDMENT 10197 Accrual to the arms involving hydroxyurea alone has been closed Patients are randomized to one of the three treatment arms as follows
1 hydroxyurea placebo plus ddI
2 hydroxyurea lower dose plus ddI
3 hydroxyurea higher dose plus ddI
This is a 24-week study with two 12-week treatment periods Patients are randomized to one of five treatment arms based upon a patients history of antiretroviral therapy naive vs experienced The five treatment arms are
1 ddI plus hydroxyurea placebo
2 hydroxyurea lower dose plus ddI placebo for 4 weeks then hydroxyurea higher dose plus ddI
3 hydroxyurea higher dose plus ddI placebo for 4 weeks then hydroxyurea higher dose plus ddI
4 hydroxyurea lower dose plus ddI
5 hydroxyurea higher dose plus ddI After the completion of week 12 patients on combination therapy remain on their current therapy and patients on ddI plus placebo have hydroxyurea replace the placebo at 1 of 2 assigned doses 11 randomization AS PER AMENDMENT 5597 If after the 24-week treatment period a patient has an RNA level less than or equal to 5000 copiesml or less than 20000 copiesml with a greater than 1 log10 decline from baseline she has the option to continue therapy open-label ddI plus hydroxyurea for an additional 24 weeks
AS PER AMENDMENT 10197 Accrual to the arms involving hydroxyurea alone has been closed Patients are randomized to one of the three treatment arms as follows
1 hydroxyurea placebo plus ddI
2 hydroxyurea lower dose plus ddI
3 hydroxyurea higher dose plus ddI
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 |
|---|---|---|---|
| 11282 | REGISTRY | DAIDS ES | None |