Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159224
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2005-09-07
Brief Title:
Induction-maintenance of Lopinavirr in HIV-infected Subjects
Sponsor:
Fundación Huésped
Organization:
Fundación Huésped
Study Overview
Official Title:
Study ACA-ARGE-04-001 A Pilot Open-Label Study Assessing Safety Tolerability Efficacy of a Simplified LopinavirRitonavir InductionMaintenance Therapy in HIV-Infected Subjects on Their First Protease Inhibitor-Based Regimen
Status:
COMPLETED
Status Verified Date:
2015-09
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 study will assess the safety tolerability and antiviral activity of a simplified PI-based treatment regimen Kaletraä compared to conventional HAART regimens in patients infected with HIV-1 who are on their first boosted-PI antiretroviral treatment regimen
The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective long-term treatment for people with HIV-1
Data from one of these trials M97-7206 an ongoing Phase II study of lopinavirritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection
The potency of the antiviral activity of Kaletra has been clearly demonstrated in a wide spectrum of patients in a number of different clinical trials6-9 The durable viral suppression seen after 4 years of therapy10 proves that it can provide effective long-term treatment for people with HIV-1
Data from one of these trials M97-7206 an ongoing Phase II study of lopinavirritonavir in combination with NRTIs suggests there may be a role for monoclass therapy with Kaletra in the treatment of HIV-1-infection
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