Switch to Maraviroc + Integrase Inhibitor
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 NRTI/NNRTIs 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Proportion of patients virologically suppressed (HIV RNA <50 copies/ml) at 48weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Mean percent change in total cholesterol, LDL, and HDL [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: Yes ]
- Number of participants with adverse events [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: Yes ]
- proportion of patients who are virologically suppressed (HIV RNA < 50 copies/ml) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- telomerase activity and telomere length. [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Maraviroc + Raltegravir or Dolutegravir
Maraviroc 300 mg tablet twice a day plus Raltegravir 400 mg tablet twice a day or Dolutegravir 50 mg tablet once a day for 48 weeks
Drug: Switch to Maraviroc + Raltegravir or Dolutegravir
Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks
Description of the study design:
The study will enroll 30 HIV-infected patients on a stable ART regimen with a suppressed HIV RNA < 50 copies/ml 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 investigator/subject preference, as the two integrate inhibitors are largely interchangeable aside from twice daily (raltegravir) vs. daily (dolutegravir) dosing.
- The primary endpoint is the proportion of patients virologically suppressed (HIV RNA < 50 copies/ml) at 48 weeks.
- Virologic suppression is an HIV RNA < 50 copies/ml.
- Virologic failure is an HIV RNA ≥ 50 copies/ml confirmed on 2 separate occasions, separated by > 1 week after viral suppression.
- 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 copies/ml) at 96 weeks.
- Telomerase activity and telomere length measured at baseline and 24, 48, and 96 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01896921
|Contact: Gregg Brogdenfirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland, Institute of Human Virology||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Gabriel Deleon, B.S. 410-706-4322 email@example.com|
|Contact: Judith Shaw 1-866-448-4448 firstname.lastname@example.org|
|Principal Investigator: David Riedel, MD|
|Principal Investigator:||David J Riedel, MD||University of Maryland|