Switch to Maraviroc + Integrase Inhibitor
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|ClinicalTrials.gov Identifier: NCT01896921|
Recruitment Status : Recruiting
First Posted : July 11, 2013
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Switch to Maraviroc + Raltegravir or Dolutegravir||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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
- Proportion of patients virologically suppressed (HIV RNA <50 copies/ml) at 48weeks. [ Time Frame: 48 weeks ]
- Mean percent change in total cholesterol, LDL, and HDL [ Time Frame: 48 and 96 weeks ]
- Number of participants with adverse events [ Time Frame: 48 and 96 weeks ]
- proportion of patients who are virologically suppressed (HIV RNA < 50 copies/ml) [ Time Frame: 96 weeks ]
- telomerase activity and telomere length. [ Time Frame: 48 and 96 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896921
|Contact: Gregg Brogdenemail@example.com|
|United States, Maryland|
|University of Maryland, Institute of Human Virology||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Gregory Brogden, BS 410-706-1660 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|