Switch to Maraviroc + Integrase Inhibitor
|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 Brogdenemail@example.com|
|United States, Maryland|
|University of Maryland, Institute of Human Virology||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Gabriel Deleon, B.S. 410-706-4322 firstname.lastname@example.org|
|Contact: Judith Shaw 1-866-448-4448 email@example.com|
|Principal Investigator: David Riedel, MD|
|Principal Investigator:||David J Riedel, MD||University of Maryland|