Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421551
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2007-01-11
Brief Title:
Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
A Randomized Multicenter Study With Non-inferiority Hypothesis Comparing the Availability to Maintain a Complete Viral Suppression by a Monotherapy of Darunavirr to a NRTI Containing Regimen Including Darunavirr in HIV-1 Infected Patients With Previous Prolonged Complete Viral Suppression ANRS 136 MONOI
Status:
COMPLETED
Status Verified Date:
2013-07
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 whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI darunavirr in HIV infected patients with full viral suppression
Detailed Description:
The chronicity of the disease which will require treatment over decades long-term adverse events associated with standard combined antiretroviral therapy emphasize the need for simpler alternative treatment strategies for HIV infection The goal of antiretroviral therapy in 2006 is the durability of treatment with less toxicity and reduced exposure to drugs Previous studies have shown that single boosted PI maintenance therapy such as lopinavir LPVr were effective in maintaining virological efficacy Furthermore in case of virological failure limited resistance has been described darunavirr a new PI has been shown to be highly potent exhibits a high genetic barrier to resistance and appears to be well tolerated This study aimed to evaluate whether darunavirr can represent a potential strategy therapeutic as single therapy in patients who have full virologic suppression At entry subjects with HIV RNA below 50 cpml switch from their current therapy which can be 2 NRTI and IP 2 NRTI and NNRTI 3 NRTI to darunavirr with their 2 NRTIs for 8 weeks Phase I If patients remain below 50 cpml and has no intolerance to darunavir at week -4 they are included in the phase II and will be randomized either to receive darunavirr alone or to continue 2 NRTI and darunavirr for until W48 Phase II Patients will be monitored at W4 W8 and then every 8 weeks until W48 for the primary endpoint To evaluate the durability and safety of this strategy patients will be followed up to W96
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 136 MONOI | None | None | None |