Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002184
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase II Stratified Randomized Double-Blind Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil ADF at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors PI and Nucleoside Reverse Transcriptase Inhibitors RTI for the Treatment of HIV-Infected Patient
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Stratified Randomized Double-Blind Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil ADF at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors PI and Nucleoside Reverse Transcriptase Inhibitors RTI for the Treatment of HIV-Infected Patients With CD4 Cell Counts 100mm3 and HIV-1 RNA Copy Numbers 5000 CopiesMl and Prior RTI Therapy But No Prior PI Therapy
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 the combination of adefovir dipivoxil at two comparative doses and nelfinavir plus saquinavir SGC administered orally Group 1 vs the combination of adefovir dipivoxil and nelfinavir plus either zidovudine lamivudine or stavudine Group 2 vs the combination of adefovir dipivoxil and saquinavir SGC plus either zidovudine lamivudine or stavudine Group 3 in HIV-infected patients with prior nucleoside reverse transcriptase inhibitor therapy but no prior exposure to protease inhibitors who have 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 at 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 double-blind dose-comparative study of the safety and efficacy of adefovir dipivoxil in combination with nelfinavir and saquinavir soft gel capsules SGC or adefovir dipivoxil in combination with nelfinavir or saquinavir SGC plus a nucleoside analog zidovudine lamivudine or stavudine
Patients will be randomized to adefovir dipivoxil with nelfinavir and saquinavir or adefovir dipivoxil with nelfinavir or saquinavir plus a nucleoside analog zidovudine lamivudine or stavudine Within each treatment arm patients will be randomized to 1 of 2 doses of adefovir dipivoxil in a blinded manner Patients randomized to receive a nucleoside analog will then be assigned to receive either zidovudine lamivudine or stavudine based upon their previous RTI therapy A daily dose of L-carnitine will be administered to all patients
Patients will be randomized to adefovir dipivoxil with nelfinavir and saquinavir or adefovir dipivoxil with nelfinavir or saquinavir plus a nucleoside analog zidovudine lamivudine or stavudine Within each treatment arm patients will be randomized to 1 of 2 doses of adefovir dipivoxil in a blinded manner Patients randomized to receive a nucleoside analog will then be assigned to receive either zidovudine lamivudine or stavudine based upon their previous RTI therapy A daily dose of L-carnitine will be administered to all patients
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?: