Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002427
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Combining Hydroxyurea HU With Didanosine ddI and Stavudine d4T for Treatment of HIV-Infected Adults
Sponsor:
Research Institute for Genetic and Human Therapy
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Study of the Safety and Antiretroviral Activity of Nine Hydroxyurea Regimens in Combination With ddI and d4T in Subjects With HIV Infection
Status:
COMPLETED
Status Verified Date:
2000-08
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 compare the safety and effectiveness of 9 doses of HU in order to find the best dose of HU to use with ddI and d4T in fighting HIV infection
HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV This combination can sharply decrease viral load level of HIV in the body with few side effects making it easy to take
HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV This combination can sharply decrease viral load level of HIV in the body with few side effects making it easy to take
Detailed Description:
The combination of HU plus ddI plus d4T appears to be suitable for long-term control of HIV in that it 1 has a novel resistancerebound profile demonstrating virus suppression even in the presence of ddI-resistant mutants 2 can produce a pronounced fall in viral load and 3 is well tolerated over 200 patients have been treated for up to 3 years with minimal side effects
Patients are stratified by antiretroviral experience naive no more than 2 weeks of therapy versus experienced more than 2 weeks Patients must discontinue all antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment arms Treatment arms are divided into 3 HU dose categories very low low and medium Within each category HU is administered daily on 3 different dosing schedules Depending on viral load patients on the very low and low dose arms may have the opportunity to intensify their HU dose at any time beyond Week 12 provided no Grade 3 or 4 HU-related toxicity is present these patients are monitored for an additional 8 weeks following intensification All patients receive ddI and d4T at the same doses every day When 50 of patients have completed 24 weeks of treatment an analysis is made to determine whether or not to continue the 52-week study without modifications Patients are monitored periodically for changes in plasma HIV RNA CD4 cell counts weight and symptoms
Patients are stratified by antiretroviral experience naive no more than 2 weeks of therapy versus experienced more than 2 weeks Patients must discontinue all antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment arms Treatment arms are divided into 3 HU dose categories very low low and medium Within each category HU is administered daily on 3 different dosing schedules Depending on viral load patients on the very low and low dose arms may have the opportunity to intensify their HU dose at any time beyond Week 12 provided no Grade 3 or 4 HU-related toxicity is present these patients are monitored for an additional 8 weeks following intensification All patients receive ddI and d4T at the same doses every day When 50 of patients have completed 24 weeks of treatment an analysis is made to determine whether or not to continue the 52-week study without modifications Patients are monitored periodically for changes in plasma HIV RNA CD4 cell counts weight and symptoms
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 |
|---|---|---|---|
| RIGHT 702 | None | None | None |