Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01068873
Status:
TERMINATED
Last Update Posted:
2020-11-02
First Post:
2010-02-12
Brief Title:
Kaletra and Maraviroc in Antiretroviral Therapy ART-Naive Patients KALMAR Study
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 10 Amendment 2
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KALMAR
Brief Summary:
The primary objective of this pilot study is to assess the efficacy of lopinavirritonavir Kaletra a protease inhibitor PI when used in combination with maraviroc Selzentry an HIV entry inhibitor for the treatment of antiretroviral naïve HIV infected patients Twenty patients will be enrolled and studied for 48 weeks
Detailed Description:
As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity This is a non-randomized open label trial in participants meeting entry requirements
Participants will be evaluated at screening baselineand weeks 4 8 12 24 36 and 48 to include clinical assessments as well as laboratory assessments
An interim analysis will be performed when all patients have reached the week 24 visit
Participants will be evaluated at screening baselineand weeks 4 8 12 24 36 and 48 to include clinical assessments as well as laboratory assessments
An interim analysis will be performed when all patients have reached the week 24 visit
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