Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105079
Status:
COMPLETED
Last Update Posted:
2011-11-02
First Post:
2005-03-04
Brief Title:
GEMINI Study - A Study of SaquinavirRitonavir in Treatment-Naive Patients With HIV-1 Infection
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A 48-week Randomized Open-label 2-arm Study to Compare the Efficacy of SaquinavirRitonavir Twice Daily BID Plus EmtricitabineTenofovir Once Daily QD Versus LopinavirRitonavir BID Plus EmtricitabineTenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 HIV-1 Infected Patients GEMINI Study
Status:
COMPLETED
Status Verified Date:
2011-09
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:
This 2 arm study will evaluate the efficacy safety and tolerability of saquinavirritonavir or lopinavirritonavir in combination with emtricitabinetenofovir in patients with human immunodeficiency virus type 1 HIV-1 infection who have received no prior HIV treatment Patients will be randomized to receive either saquinavirritonavir 1000100mg oral po twice daily bid emtricitabinetenofovir 200300mg po once daily qd or lopinavirritonavir 400100mg po bid emtricitabinetenofovir 200300mg po qd The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
Detailed Description:
None
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