NCT01896921

Switch to Maraviroc + Integrase Inhibitor

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

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 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. Primary endpoint: * The primary endpoint is the proportion of patients virologically suppressed (HIV RNA \< 50 copies/ml) at 48 weeks. Definitions: * 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. 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 copies/ml) at 96 weeks. Exploratory endpoints: * Telomerase activity and telomere length measured at baseline and 24, 48, and 96 weeks.

Conditions

• HIV

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-09-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2013-07-11
• Last updated: 2021-10-20
• Results posted: 2019-11-19

Locations

1 site across 1 country: United States