Switch to Maraviroc + Integrase Inhibitor

NCT01896921 | Completed Phase 3 Results DMC

• 1 other identifier: HP-00056162
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.

  Number of patients virologically suppressed (HIV RNA \<50 copies/ml) at 48 weeks.

  48 weeks

Secondary Outcomes (2)

• Number of Participants With Adverse Events

  96 weeks

• Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)

  96 weeks

Study Arms (1)

Maraviroc + Raltegravir or Dolutegravir

EXPERIMENTAL

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

Interventions

Switch to Maraviroc + Raltegravir or Dolutegravir DRUG

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

Maraviroc + Raltegravir or Dolutegravir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection
• Age between 18 and 75 years
• CD4 count nadir ≥ 250 cells/mm3
• HIV RNA ≤ 50 copies/ml for ≥ 12 months while taking any ART regimen
• o One virologic blip ≤ 400 copies/ml permissible within the 12 months
• CCR5 tropic virus as defined by:
• trofile/tropism testing if available, OR
• DNA trofile if no trofile/tropism test available and CD4 nadir 250-499 cells/mm3, OR
• CD4 nadir ≥ 500 cells/mm3

You may not qualify if:

• Age \< 18 or \> 75 years
• CD4 count nadir \< 250 cells/mm3
• Dual/mixed or X4 tropic virus if tested prior to viral suppression or if performed by DNA trofile testing at any time
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times the upper limits of normal
• Women who:
• are currently pregnant or breastfeeding
• are of child-bearing age and do not agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
• History of any malignancy except non-melanoma skin cancer
• Concomitant use of drugs known to impact or be impacted in terms of pharmacokinetics or drug-drug interactions with either raltegravir or maraviroc. This includes:
• Inducers of UGT1A1 (such as rifampin, phenytoin, phenobarbital rifabutin, St. John's wort)
• CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin, nefazodone, and telithromycin)
• CYP3A inducers (such as rifampin, carbamazepine, phenobarbital and phenytoin)
• Subject requires or is anticipated to require any of the prohibited medications noted in the protocol
• Enrollment in an experimental protocol having received investigational agents (antiretroviral or non-antiretroviral) within 30 days of study enrollment
• Chronic active hepatitis B infection as defined by presence of HBsAg

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Raltegravir Potassium; dolutegravir

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gregg Brogden
• Organization: University of Maryland

gbrogden@ihv.umaryland.edu

4107061660

Study Officials

• David J Riedel, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 11, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 20, 2021
• Results First Posted: November 19, 2019

Record last verified: 2021-10

Locations

US (1)