Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122603
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-07-19
Brief Title:
Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients ANRS127
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Efficacy and Safety of Regimens Restricted to a Combination of Two Boosted Protease Inhibitors as Potent Antiretroviral Therapy in HIV-1 Infected Patients ANRS 127 2IP
Status:
COMPLETED
Status Verified Date:
2011-12
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 virological efficacy and safety of two double protease inhibitor regimens atazanavirfosamprenavirritonavir 300 mg once daily 700100 mg twice daily versus atazanavirsaquinavirritonavir 3001500100 mg once daily in protease inhibitor naive HIV-1 patients
Detailed Description:
The purpose of this randomized open-label study is to evaluate virological efficacy and safety of two double protease inhibitor regimens atazanavirfosamprenavirritonavir 300 mg once daily 700100 mg twice daily versus atazanavirsaquinavirritonavir 3001500100 mg once daily in protease inhibitor naive HIV-1 patients
Patients with CD4 cell counts over or equal to 200mm3 HIV viral load between 10000 and 750000 copies per milliliter and wild-type genotype at baseline will be eligible This multicenter study will enroll 60 patients n30 in each group The planned duration of the study is 48 weeks from the enrolment of the last subject
The primary efficacy endpoint will be virologic success defined as HIV RNA levels below 50 copiesml after 16 weeks of initial treatment The durability of this response will be evaluated and patients will be followed for 48 weeks
The primary safety endpoint will be treatment interruptions because of adverse effects
Patients with CD4 cell counts over or equal to 200mm3 HIV viral load between 10000 and 750000 copies per milliliter and wild-type genotype at baseline will be eligible This multicenter study will enroll 60 patients n30 in each group The planned duration of the study is 48 weeks from the enrolment of the last subject
The primary efficacy endpoint will be virologic success defined as HIV RNA levels below 50 copiesml after 16 weeks of initial treatment The durability of this response will be evaluated and patients will be followed for 48 weeks
The primary safety endpoint will be treatment interruptions because of adverse effects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS 127 2 IP | None | None | None |