- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland, Institute of Human Virology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.
Time Frame: 48 weeks
|
Number of patients virologically suppressed (HIV RNA <50 copies/ml) at 48 weeks.
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: 96 weeks
|
Number of participants with adverse events
|
96 weeks
|
Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)
Time Frame: 96 weeks
|
Number of patients who are virologically suppressed (HIV RNA < 50 copies/ml)
|
96 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: David J Riedel, MD, University of Maryland, College Park
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- HIV Fusion Inhibitors
- Viral Fusion Protein Inhibitors
- CCR5 Receptor Antagonists
- Raltegravir Potassium
- Maraviroc
- Dolutegravir
Other Study ID Numbers
- HP-00056162
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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