Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160849
Status:
COMPLETED
Last Update Posted:
2005-10-21
First Post:
2005-09-08
Brief Title:
Lopinavirr Monotherapy as Maintenance Therapy After Long Term Viral Suppression
Sponsor:
Universidade Federal do Rio de Janeiro
Organization:
Universidade Federal do Rio de Janeiro
Study Overview
Official Title:
Study on the Feasibility of Antiretroviral Therapy With a Single Agent - Lopinavirr - in Patients Treated With HAART and With Viral Load Below 80 CopiesMl
Status:
COMPLETED
Status Verified Date:
2005-07
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:
1 Objectives Primary
To investigate the possibility of maintaining virological suppression of HIV in infected patients switching them to LPVr as the only antiretroviral agent
To assess the immunological response in patients who switched to LPVr as single agent based on the observation of changes in the serum levels of CD4 cells
Secondary
To investigate the rate of clinical and laboratorial adverse events in the two treatment groups
To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups in case of virological failure of the current regimen
To describe the adherence to the prescribed regimen in the two treatment groups
To describe changes in body fat distribution abdominal arms and thigh circumference and in the lipid profile in patients from the two treatment groups
To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups
2 Patient population
The 60 patients were selected by the investigators according to the studys inclusion and exclusion criteria and were divided into 2 groups with 30 patients each
3 Study design
The study is multicentric open-label randomized Virological immunological and clinical failures will be analyzed in both groups In addition data on clinical or laboratorial toxicity and compliance are being recorded
4 Regime
Group 1 maintenance of the currently used antiretroviral therapy
Group 2 switch to LPVr antiretroviral monotherapy in the dose of 400100 mg 1212 hs with food Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors Efavirenz or Nevirapine were instructed to take 4 capsules of Lopinavirr each 12 hs during the first 14 days of therapy up to Week 2 visit
5 Duration
96 weeks of treatment
To investigate the possibility of maintaining virological suppression of HIV in infected patients switching them to LPVr as the only antiretroviral agent
To assess the immunological response in patients who switched to LPVr as single agent based on the observation of changes in the serum levels of CD4 cells
Secondary
To investigate the rate of clinical and laboratorial adverse events in the two treatment groups
To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups in case of virological failure of the current regimen
To describe the adherence to the prescribed regimen in the two treatment groups
To describe changes in body fat distribution abdominal arms and thigh circumference and in the lipid profile in patients from the two treatment groups
To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups
2 Patient population
The 60 patients were selected by the investigators according to the studys inclusion and exclusion criteria and were divided into 2 groups with 30 patients each
3 Study design
The study is multicentric open-label randomized Virological immunological and clinical failures will be analyzed in both groups In addition data on clinical or laboratorial toxicity and compliance are being recorded
4 Regime
Group 1 maintenance of the currently used antiretroviral therapy
Group 2 switch to LPVr antiretroviral monotherapy in the dose of 400100 mg 1212 hs with food Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors Efavirenz or Nevirapine were instructed to take 4 capsules of Lopinavirr each 12 hs during the first 14 days of therapy up to Week 2 visit
5 Duration
96 weeks of treatment
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