Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116636
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2005-06-29
Brief Title:
Study of the 48-Week Virologic and Immunologic Response to LopinavirRitonavir Kaletra in HIV Positive Adult Patients
Sponsor:
Therapeutic Concepts
Organization:
Therapeutic Concepts
Study Overview
Official Title:
A Phase II Open Label Single Arm Study of the 48-Week Virologic and Immunologic Response to LopinavirRitonavir Kaletra as a Single Agent in a Cohort of HIV Positive Adult Patients
Status:
COMPLETED
Status Verified Date:
2005-06
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:
Expected Enrollment 40 patients
Study Start Date June 2005
Study Objectives
To conduct a pilot study to assess the safety tolerability and antiviral activity of Kaletra 400100 mg taken twice a day bid in antiretroviral ARV-naïve HIV-infected patients at Week 48
Primary Objectives
To determine the proportion of patients with HIV RNA 400 copiesmL at weeks 24 and 48
To determine the proportion of patients with HIV RNA 50 at weeks 24 and 48
To elucidate the specific adverse event AE profile of Kaletra single agent therapy
Secondary Objectives
To assess the proportion of patients below the limit of quantification LOQ at each visit Patients will be observed at baseline weeks 4 8 12 16 20 24 28 32 36 40 44 and 48
To determine the time to HIV RNA reaching 400 and 50 copiesmL
To determine the time to virologic failure
To assess change from baseline at each visit for HIV RNA and CD4 count at weeks 4 8 12 24 and 48
To assess changes in genotype from baseline to time of confirmed virologic failure 2 consecutive HIV RNA measurements 400 copiesmL after suppressing to 400 copiesmL or at time of treatment intensification
To characterize changes in lipid and triglyceride concentrations over time and the effect of treatment with appropriate drugs fibrate or statin if necessary on these elevations
To evaluate the safety and tolerability of subjects through 48 weeks of drug exposure
To describe virologic response following intensification in Kaletra single agent virologic failures
Study Start Date June 2005
Study Objectives
To conduct a pilot study to assess the safety tolerability and antiviral activity of Kaletra 400100 mg taken twice a day bid in antiretroviral ARV-naïve HIV-infected patients at Week 48
Primary Objectives
To determine the proportion of patients with HIV RNA 400 copiesmL at weeks 24 and 48
To determine the proportion of patients with HIV RNA 50 at weeks 24 and 48
To elucidate the specific adverse event AE profile of Kaletra single agent therapy
Secondary Objectives
To assess the proportion of patients below the limit of quantification LOQ at each visit Patients will be observed at baseline weeks 4 8 12 16 20 24 28 32 36 40 44 and 48
To determine the time to HIV RNA reaching 400 and 50 copiesmL
To determine the time to virologic failure
To assess change from baseline at each visit for HIV RNA and CD4 count at weeks 4 8 12 24 and 48
To assess changes in genotype from baseline to time of confirmed virologic failure 2 consecutive HIV RNA measurements 400 copiesmL after suppressing to 400 copiesmL or at time of treatment intensification
To characterize changes in lipid and triglyceride concentrations over time and the effect of treatment with appropriate drugs fibrate or statin if necessary on these elevations
To evaluate the safety and tolerability of subjects through 48 weeks of drug exposure
To describe virologic response following intensification in Kaletra single agent virologic failures
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