Trial Outcomes & Findings for Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 (NCT NCT00993148)

NCT ID: NCT00993148

Last Updated: 2014-09-05

Results Overview

Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-09-05

Participant Flow

Participant milestones

Measure	Maraviroc + Darunavir/Ritonavir maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Maraviroc + Darunavir/Ritonavir maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Study Lost to Follow-up	2
Overall Study never initiated treatment	1

Baseline Characteristics

Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1

Baseline characteristics by cohort

Measure	Maraviroc + Darunavir/Ritonavir n=25 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Age, Continuous	38 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	5 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Median HIV-1 RNA	4.62 log 10 copies n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Percentage of Participants With Plasma HIV-1 RNA >50	12.5 percentage of participants Interval 2.7 to 32.4

SECONDARY outcome

Timeframe: 24 weeks

Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Percentage of Participants With Virologic Failure or Off Study Treatment Regimen	12.5 percentage of participants Interval 2.7 to 32.4

SECONDARY outcome

Timeframe: 48 weeks

Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL	8.3 percentage of participants Interval 1.0 to 27.0

SECONDARY outcome

Timeframe: 96 weeks

Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher	1 participants

SECONDARY outcome

Timeframe: At study entry and at the time of virologic failure

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES	0 participants

SECONDARY outcome

Timeframe: Week 24

Drug adherence, assessed as number of participants with missed doses over four-day recall

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Drug Adherence, Number of Participants With Missed Doses	0 participants

SECONDARY outcome

Timeframe: 24 hours

Average trough concentration (Ctrough) of maraviroc

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Trough Concentrations (Ctrough) of Maraviroc	39.3 ng/mL Standard Deviation 22.8

SECONDARY outcome

Timeframe: 96 weeks

Median changes from baseline in peripheral CD4+ T-cell count

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=24 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Median CD4 Count Change From Baseline	247 cells per mm^3 Interval 119.0 to 340.0

SECONDARY outcome

Timeframe: 96 weeks

Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL

Outcome measures

Measure	Maraviroc + Darunavir/Ritonavir n=20 Participants maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL	10 percentage of participants Interval 1.2 to 31.7

Adverse Events

Maraviroc + Darunavir/Ritonavir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Babafemi Taiwo

Northwestern University

Phone: 312-695-5085

Email: b-taiwo@northwestern.edu

Results disclosure agreements

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