Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002379
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Stratified Randomized Open-Label Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil and Indinavir in Combination With Zidovudine Lamivudine or Stavudine for the Treatment of Therapy Naive HIV-Infected Patients With CD4 Cell Counts 100 Cellsmm3 and HIV-1 RNA Copy Numbers 5000 CopiesMl
Status:
COMPLETED
Status Verified Date:
1998-10
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 evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine lamivudine or stavudine in HIV-infected patients with CD4 cell counts 100 cellsmm3 and an HIV-1 RNA baseline copy number 5000 copiesml To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection 500 copiesml by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20 To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24
Detailed Description:
This protocol is a stratified randomized open-label study of the safety and efficacy of adefovir dipivoxil with indinavir as quadruple therapy in combination with zidovudine and lamivudine or as triple combination administered with either zidovudine or lamivudine or stavudine for 48 weeks in the treatment of HIV-infected patients with CD4 cell counts 100mm3 and an HIV-1 RNA baseline copy number 5000 copiesml Patients will be randomized to adefovir dipivoxil indinavir zidovudine and lamivudine or adefovir dipivoxil indinavir and a nucleoside inhibitor randomly assigned to receive zidovudine lamivudine or stavudine or to indinavir zidovudine and lamivudine Additionally a daily dose of L-carnitine will be administered to all patients randomized to an arm containing adefovir dipivoxil
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?: