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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00993148
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : August 19, 2014
Last Update Posted : September 5, 2014
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Maraviroc + Darunavir/Ritonavir maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily

Participant Flow:   Overall Study
    Maraviroc + Darunavir/Ritonavir
Lost to Follow-up                2 
never initiated treatment                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
HIV-infected treatment naïve participants with R5 virus

Reporting Groups
Maraviroc + Darunavir/Ritonavir maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily

Baseline Measures
   Maraviroc + Darunavir/Ritonavir 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Inter-Quartile Range)
 (31 to 43) 
[Units: Participants]
Female   3 
Male   22 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   1 
Not Hispanic or Latino   23 
Unknown or Not Reported   1 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   3 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   5 
White   15 
More than one race   0 
Unknown or Not Reported   2 
Region of Enrollment 
[Units: Participants]
United States   25 
Median HIV-1 RNA [1] 
[Units: Log 10 copies]
Median (Inter-Quartile Range)
 (4.18 to 4.80) 
[1] Median HIV-1 RNA

  Outcome Measures

1.  Primary:   Percentage of Participants With Plasma HIV-1 RNA >50   [ Time Frame: 24 weeks ]

2.  Secondary:   Percentage of Participants With Virologic Failure or Off Study Treatment Regimen   [ Time Frame: 24 weeks ]

3.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL   [ Time Frame: 48 weeks ]

4.  Secondary:   Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher   [ Time Frame: 96 weeks ]

5.  Secondary:   Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES   [ Time Frame: At study entry and at the time of virologic failure ]

6.  Secondary:   Drug Adherence, Number of Participants With Missed Doses   [ Time Frame: Week 24 ]

7.  Secondary:   Trough Concentrations (Ctrough) of Maraviroc   [ Time Frame: 24 hours ]

8.  Secondary:   Median CD4 Count Change From Baseline   [ Time Frame: 96 weeks ]

9.  Secondary:   Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL   [ Time Frame: 96 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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

Publications of Results:

Responsible Party: Babafemi Taiwo, Northwestern University 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