Viewing Study NCT01896921



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Last Modification Date: 2024-10-26 @ 11:09 AM
Study NCT ID: NCT01896921
Status: COMPLETED
Last Update Posted: 2021-10-20
First Post: 2013-06-27

Brief Title: Switch to Maraviroc Integrase Inhibitor
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Switch to Maraviroc and Integrase Strand Transfer Inhibitor Combination Therapy a Triple Class-Sparing Regimen for the Treatment of HIV-1-Infected Patients on Suppressive Antiretroviral Regimens
Status: COMPLETED
Status Verified Date: 2021-10
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 clinical study proposes to evaluate the combination of maraviroc with an integrase strand transfer inhibitor either raltegravir or dolutegravir in antiretroviral-experienced patients to document the efficacy safety and tolerability of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications by avoidance of NRTINNRTIs and PIs The development of an alternative ART regimen which lessens the risk of metabolic complications could improve long-term adherence and reduce the risk of certain co-morbidities associated with long-term ART use If this new combination is found to be as efficacious as the standard regimen with enhanced tolerability and improved metabolic effects there is great potential for altering the current practice of HIV medicine
Detailed Description: Description of the study design

The study will enroll 30 HIV-infected patients on a stable ART regimen with a suppressed HIV RNA 50 copiesml for at least one year Patients will be switched to the experimental regimen maraviroc 300 mg twice a day plus either raltegravir 400 mg twice a day or dolutegravir 50 mg once a-day and followed for 96 weeks The decision to use raltegravir or dolutegravir will be left to investigatorsubject preference as the two integrate inhibitors are largely interchangeable aside from twice daily raltegravir vs daily dolutegravir dosing

Primary endpoint

The primary endpoint is the proportion of patients virologically suppressed HIV RNA 50 copiesml at 48 weeks

Definitions

Virologic suppression is an HIV RNA 50 copiesml
Virologic failure is an HIV RNA 50 copiesml confirmed on 2 separate occasions separated by 1 week after viral suppression

Secondary endpoints

The percent change in total cholesterol LDL and HDL at 48 and 96 weeks
The number of adverse events
The proportion of patients who are virologically suppressed HIV RNA 50 copiesml at 96 weeks

Exploratory endpoints

Telomerase activity and telomere length measured at baseline and 24 48 and 96 weeks

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