Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008866
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2001-01-18
Brief Title:
Effectiveness of Early or Delayed Addition of Hydroxyurea to a Three-Drug Anti-HIV Drug Combination Including Didanosine in Advanced HIV Patients Who Failed a First or Second Anti-HIV Triple-Drug Therapy
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 Double-Blind Randomized Study to Determine the Effect of Adding Delayed Versus Immediate Hydroxyurea to a Genotypic Based ddI-Containing Three-Drug Antiretroviral Regimen on the Recovery of Total CD4 T-Cell Counts and Suppression of Plasma Viral Load in Advanced HIV-1 Infected Subjects Failing a First or Second Triple Combination Therapy
Status:
WITHDRAWN
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:
The purpose of this study is to find out whether or not the addition of hydroxyurea to didanosine ddI and other anti-HIV medications will result in better control of HIV infection
The Food and Drug Administration FDA has approved ddI for treating HIV infections Hydroxyurea is approved for treating some cancers and blood disorders It works against HIV-1 when combined with ddI Researchers need to look at how well patients may respond to hydroxyurea in combination with ddI and other anti-HIV drugs and at any side effects
The Food and Drug Administration FDA has approved ddI for treating HIV infections Hydroxyurea is approved for treating some cancers and blood disorders It works against HIV-1 when combined with ddI Researchers need to look at how well patients may respond to hydroxyurea in combination with ddI and other anti-HIV drugs and at any side effects
Detailed Description:
Increasing frequency of treatment failures on potent antiretroviral therapy has accelerated the need for new classes of agents Hydroxyurea an agent broadly used for its antineoplastic properties has been shown to inhibit HIV-1 in vitro and in vivo when combined with the nucleoside analogue reverse transcriptase inhibitor didanosine ddI There is an urgent need to prospectively test the safety tolerability and efficacy of hydroxyurea in late-stage treatment-experienced patients
Patients undergo genotypic analysis after registration to Step 1 Genotypic antiretroviral resistance test GART along with a patients antiretroviral drug history will be used to select an optimal antiretroviral drug regimen non-study drugs for each patient Patients willing to initiate the GART-based regimen are randomized at Week 5 into Step 2 They are stratified first by level of ddI resistance then within each strata by CD4 T cell count and then assigned to 1 of 3 treatment arms to start all study drugs ddI and hydroxyurea and non-study antiretroviral drugs on the day of randomization Patients in Arm A receive ddI and hydroxyurea placebo Arm B ddI and hydroxyurea placebo that is replaced by hydroxyurea after 8 weeks and Arm C ddI and hydroxyurea Patients receive treatment for 48 weeks Patients are checked regularly for immunologic virologic and metabolic parameters Patients may elect to participate in substudy A5070s which explores the effects of study treatment on T cell populations and other immunologic evaluations
Patients undergo genotypic analysis after registration to Step 1 Genotypic antiretroviral resistance test GART along with a patients antiretroviral drug history will be used to select an optimal antiretroviral drug regimen non-study drugs for each patient Patients willing to initiate the GART-based regimen are randomized at Week 5 into Step 2 They are stratified first by level of ddI resistance then within each strata by CD4 T cell count and then assigned to 1 of 3 treatment arms to start all study drugs ddI and hydroxyurea and non-study antiretroviral drugs on the day of randomization Patients in Arm A receive ddI and hydroxyurea placebo Arm B ddI and hydroxyurea placebo that is replaced by hydroxyurea after 8 weeks and Arm C ddI and hydroxyurea Patients receive treatment for 48 weeks Patients are checked regularly for immunologic virologic and metabolic parameters Patients may elect to participate in substudy A5070s which explores the effects of study treatment on T cell populations and other immunologic evaluations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Substudy AACTG A5070s | Registry Identifier | DAIDS ES | None |
| 10905 | REGISTRY | None | None |
| ACTG A5069 | None | None | None |
| AACTG A5069 | None | None | None |