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

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ClinicalTrials.gov Identifier: NCT00993148
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : August 19, 2014
Last Update Posted : September 5, 2014
Sponsor:
Collaborators:
Pfizer
Tibotec, Inc
Information provided by (Responsible Party):
Babafemi Taiwo, Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV-1 Infection
HIV Infections
Interventions Drug: maraviroc
Drug: darunavir
Drug: ritonavir
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Period Title: Overall Study
Started 25
Completed 22
Not Completed 3
Reason Not Completed
Lost to Follow-up             2
never initiated treatment             1
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
HIV-infected treatment naïve participants with R5 virus
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 25 participants
38
(31 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
3
  12.0%
Male
22
  88.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
1
   4.0%
Not Hispanic or Latino
23
  92.0%
Unknown or Not Reported
1
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  12.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  20.0%
White
15
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
   8.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
Median HIV-1 RNA   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Log 10 copies
Number Analyzed 25 participants
4.62
(4.18 to 4.80)
[1]
Measure Description: Median HIV-1 RNA
1.Primary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA >50
Hide Description Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(2.7 to 32.4)
2.Secondary Outcome
Title Percentage of Participants With Virologic Failure or Off Study Treatment Regimen
Hide Description Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.5
(2.7 to 32.4)
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL
Hide Description Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(1.0 to 27.0)
4.Secondary Outcome
Title Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher
Hide Description 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
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
1
5.Secondary Outcome
Title Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES
Hide Description [Not Specified]
Time Frame At study entry and at the time of virologic failure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Drug Adherence, Number of Participants With Missed Doses
Hide Description Drug adherence, assessed as number of participants with missed doses over four-day recall
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
0
7.Secondary Outcome
Title Trough Concentrations (Ctrough) of Maraviroc
Hide Description Average trough concentration (Ctrough) of maraviroc
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
39.3  (22.8)
8.Secondary Outcome
Title Median CD4 Count Change From Baseline
Hide Description Median changes from baseline in peripheral CD4+ T-cell count
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 24
Median (Inter-Quartile Range)
Unit of Measure: cells per mm^3
247
(119 to 340)
9.Secondary Outcome
Title Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL
Hide Description Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
Time Frame 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description:
maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10
(1.2 to 31.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maraviroc + Darunavir/Ritonavir
Hide Arm/Group Description maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
All-Cause Mortality
Maraviroc + Darunavir/Ritonavir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc + Darunavir/Ritonavir
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maraviroc + Darunavir/Ritonavir
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Babafemi Taiwo
Organization: Northwestern University
Phone: 312-695-5085
Responsible Party: Babafemi Taiwo, Northwestern University
ClinicalTrials.gov Identifier: NCT00993148     History of Changes
Other Study ID Numbers: MIDAS
First Submitted: October 8, 2009
First Posted: October 12, 2009
Results First Submitted: July 28, 2014
Results First Posted: August 19, 2014
Last Update Posted: September 5, 2014