Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002230
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Placebo-Controlled Study of the Safety and Efficacy of Efavirenz Didanosine and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients
Sponsor:
Northwestern University
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Placebo-Controlled Study of the Safety and Efficacy of Efavirenz Didanosine and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
1999-06
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 virologic benefits associated with the addition of hydroxyurea HU to combination drug therapy with didanosine ddI stavudine d4T and efavirenz DMP in HIV-infected patients To assess the safety and tolerance of this regimen with or without HU
Detailed Description:
HU or placebo is added 30-60 days after the initiation of DMP ddI and d4T combination therapy Patients are stratified according to antiretroviral experience naive or experienced Patients are followed for 48 weeks to determine safety efficacy and effect of treatment on viral immunologicand biochemical parameters
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?: