Trial Outcomes & Findings for Switch to Maraviroc + Integrase Inhibitor (NCT NCT01896921)

NCT ID: NCT01896921

Last Updated: 2021-10-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 7 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2021-10-20

Participant Flow

Participant milestones

Measure	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 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
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Switch to Maraviroc + Integrase Inhibitor

Baseline characteristics by cohort

Measure	Maraviroc + Raltegravir or Dolutegravir n=7 Participants 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 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

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

Outcome measures

Measure

Maraviroc + Raltegravir or Dolutegravir n=7 Participants 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 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

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

5 Participants

SECONDARY outcome

Timeframe: 96 weeks

Number of participants with adverse events

Outcome measures

Measure

Maraviroc + Raltegravir or Dolutegravir n=7 Participants 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 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

Number of Participants With Adverse Events

3 Participants

SECONDARY outcome

Timeframe: 96 weeks

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

Outcome measures

Measure

Maraviroc + Raltegravir or Dolutegravir n=7 Participants 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 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

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

4 Participants

Adverse Events

Maraviroc + Raltegravir or Dolutegravir

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Maraviroc + Raltegravir or Dolutegravir n=7 participants at risk 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 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
Endocrine disorders Hyperglycemia	14.3% 1/7 • Number of events 1 • 96 weeks
Musculoskeletal and connective tissue disorders Mechanical fall	14.3% 1/7 • Number of events 1 • 96 weeks
Cardiac disorders Chest pain	14.3% 1/7 • Number of events 1 • 96 weeks

Other adverse events

Adverse event data not reported

Additional Information

Gregg Brogden

University of Maryland

Phone: 4107061660

Email: gbrogden@ihv.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place