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CompletedNCT01896921Updated Oct 20, 2021Results posted

Switch to Maraviroc + Integrase Inhibitor

A Phase 3 interventional study of Switch to Maraviroc + Raltegravir or Dolutegravir in HIV, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by University of Maryland, Baltimore · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • HIV

Keywords

  • HIV
03

In context

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • DrugSwitch 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

06

What researchers measure

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.

    Time frame: 48 weeks

Secondary outcomes

  1. Number of Participants With Adverse Events

    Number of participants with adverse events

    Time frame: 96 weeks

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

    Number of patients who are virologically suppressed (HIV RNA \< 50 copies/ml)

    Time frame: 96 weeks

07

Results

Posted Nov 19, 2019

Participant flow

Participant flow — Overall Study
MilestoneMaraviroc + Raltegravir or Dolutegravir
Started7
Completed5
Not completed2

Outcome measures

PrimaryNumber 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.

Time frame:
48 weeks
Reported as:
Count of participants · Participants
Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.
ParticipantsMaraviroc + Raltegravir or Dolutegravir
Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.5
SecondaryNumber of Participants With Adverse Events

Number of participants with adverse events

Time frame:
96 weeks
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsMaraviroc + Raltegravir or Dolutegravir
Number of Participants With Adverse Events3
SecondaryNumber of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)

Number of patients who are virologically suppressed (HIV RNA \< 50 copies/ml)

Time frame:
96 weeks
Reported as:
Count of participants · Participants
Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)
ParticipantsMaraviroc + Raltegravir or Dolutegravir
Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)4

Adverse events

Collected over 96 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Maraviroc + Raltegravir or Dolutegravir0/7 (0%)3/7 (42.9%)0/7 (0%)
Most frequent serious events
Most frequent serious events
EventMaraviroc + Raltegravir or Dolutegravir
HyperglycemiaEndocrine disorders1/7
Mechanical fallMusculoskeletal and connective tissue disorders1/7
Chest painCardiac disorders1/7

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Maraviroc + Raltegravir or Dolutegravir
<=18 years0
Between 18 and 65 years6
>=65 years1
Age, Continuous
Age, Continuous(years)Maraviroc + Raltegravir or Dolutegravir
Median58 (54 to 62)
Sex: Female, Male
Sex: Female, Male(Participants)Maraviroc + Raltegravir or Dolutegravir
Female0
Male7
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Maraviroc + Raltegravir or Dolutegravir
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American6
White1
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Maraviroc + Raltegravir or Dolutegravir
United States7
08

Study locations

1 site
  • University of Maryland, Institute of Human Virology
    Baltimore, Maryland 21201, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 26, 2014

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01896921
Lead sponsor
University of Maryland, Baltimore
Responsible party
David Riedel (Assistant Professor, University of Maryland, Baltimore) — Principal investigator
First posted
Jul 11, 2013
Start date
Sep 2013
Primary completion
Dec 2018
Completion
Dec 2018
Results posted
Nov 19, 2019
Last update
Oct 20, 2021

Study contacts

David J Riedel, MD
principal investigator · University of Maryland, College Park

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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