Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000916
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copiesml of HIV RNA in Their Blood
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copiesml of HIV RNA in the Plasma
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:
This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications It will follow the effect of these medication changes including the addition of hydroxyurea HU on long-term viral suppression Other medications which may be added include didanosine ddI andor stavudine d4T
Patients receiving combination antiretroviral therapy with indinavir IDV zidovudine ZDVor d4T and lamivudine 3TC show viral suppression for two years or more Discontinuation of one or two of these drugs results in prompt loss of the viral suppression Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression
Patients receiving combination antiretroviral therapy with indinavir IDV zidovudine ZDVor d4T and lamivudine 3TC show viral suppression for two years or more Discontinuation of one or two of these drugs results in prompt loss of the viral suppression Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression
Detailed Description:
Previous ACTG studies show that discontinuation of one or two of a three-drug regimen IDV ZDV 3TC leads to prompt loss of viral suppression in the plasma In this trial it will be determined whether adding hydroxyurea HU to a suppressive regimen increases long term viral suppression Important safety information on the tolerance of HU regimen will be characterized in asymptomatic patients with viral suppression
Patients are equally randomized to one of three arms and receive treatment as followsArm A IDV plus ddI plus d4T plus HU placebo Arm B IDV plus ddI plus d4T plus HU Arm C IDV plus 3TCZDV or d4T plus 3TC Patients are monitored every 8 weeks with plasma HIV RNA levels and CD4 cell counts
Patients are equally randomized to one of three arms and receive treatment as followsArm A IDV plus ddI plus d4T plus HU placebo Arm B IDV plus ddI plus d4T plus HU Arm C IDV plus 3TCZDV or d4T plus 3TC Patients are monitored every 8 weeks with plasma HIV RNA levels and CD4 cell counts
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 |
|---|---|---|---|
| ACTG A5025 | Registry Identifier | DAIDS ES | None |
| 10873 | REGISTRY | None | None |