Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335270
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2006-06-07
Brief Title:
A Randomized Prospective Study of the Efficacy Safety and Tolerability of Two Doses of GW433908Ritonavir Given With AbacavirLamivudine Fixed Dose Combination
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Randomized Prospective Study of the Efficacy Safety and Tolerability of Two Doses of GW433908Ritonavir Given With AbacavirLamivudine Fixed Dose Combination
Status:
COMPLETED
Status Verified Date:
2013-05
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 evaluate the antiretroviral efficacy safety and tolerability of fos-amprenavir boosted with either of two doses of ritonavir RTV when administered in combination with ABC3TC abacavirlamivudine Epzicom FDC fixed dose combination in a once-daily regimen over 96 weeks in ART-naïve HIV-infected adults
Detailed Description:
The optimal long-term management of HIV-1 infection necessitates the chronic use of highly effective well-tolerated antiretroviral ARV combination therapy which ideally can preserve future treatment options Current preferred standard treatment for HIV consists of a regimen composed of a protease inhibitor PI or a non-nucleoside reverse transcriptase inhibitor NNRTI plus 2 nucleoside reverse transcriptase inhibitors NRTIs A recent trend that may contribute to improving rates of treatment response is to use regimens with fewer pills and once daily dosing This study is designed to assess two PI options that consist of four or five pills taken once daily - these options may also offer advantages in terms of metabolic consequences
The primary objective of this multi-center open-label randomized two-arm pilot study is to evaluate the antiretroviral efficacy safety and tolerability adverse events and metabolic profile of fos-amprenavir fAPV boosted with either of two doses of ritonavir RTV when administered in combination with ABC3TC abacavirlamivudine Epzicom FDC fixed dose combination in a once-daily regimen over 48 weeks in ART-naïve HIV-infected adults Approximately 100 subjects will be enrolled from about 10 sites in the United States Subjects must be 18 years of age be ART-naïve 7 days of prior therapy with any licensed or investigational ARV drugs and have a plasma HIV-1 RNA1000 copiesmL A CD4 cell count 50 cellsmm3 was initially required for eligibility Amendment 1 has dropped this as a requirement Subjects will be stratified at entry according to their screening plasma HIV-1 RNA level 100000 copiesmL or 100000 copiesmL Eligible subjects will be randomized 11 to one of the following two treatment arms for 96 weeks fAPV 1400 mgRTV 100 mg QD plus ABC 600 mg3TC 300 mg FDC QD Treatment Arm A or fAPV 1400 mgRTV 200 mg QD plus ABC 600 mg3TC 300 mg FDC QD Treatment Arm B
The primary objective of this multi-center open-label randomized two-arm pilot study is to evaluate the antiretroviral efficacy safety and tolerability adverse events and metabolic profile of fos-amprenavir fAPV boosted with either of two doses of ritonavir RTV when administered in combination with ABC3TC abacavirlamivudine Epzicom FDC fixed dose combination in a once-daily regimen over 48 weeks in ART-naïve HIV-infected adults Approximately 100 subjects will be enrolled from about 10 sites in the United States Subjects must be 18 years of age be ART-naïve 7 days of prior therapy with any licensed or investigational ARV drugs and have a plasma HIV-1 RNA1000 copiesmL A CD4 cell count 50 cellsmm3 was initially required for eligibility Amendment 1 has dropped this as a requirement Subjects will be stratified at entry according to their screening plasma HIV-1 RNA level 100000 copiesmL or 100000 copiesmL Eligible subjects will be randomized 11 to one of the following two treatment arms for 96 weeks fAPV 1400 mgRTV 100 mg QD plus ABC 600 mg3TC 300 mg FDC QD Treatment Arm A or fAPV 1400 mgRTV 200 mg QD plus ABC 600 mg3TC 300 mg FDC QD Treatment Arm B
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