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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Tibotec, Inc
Information provided by (Responsible Party):
Babafemi Taiwo, Northwestern University
ClinicalTrials.gov Identifier:
NCT00993148
First received: October 8, 2009
Last updated: August 26, 2014
Last verified: August 2014
Results First Received: July 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV-1 Infection
HIV Infections
Interventions: Drug: maraviroc
Drug: darunavir
Drug: ritonavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
  Description
Maraviroc + Darunavir/Ritonavir maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily

Participant Flow:   Overall Study
    Maraviroc + Darunavir/Ritonavir  
STARTED     25  
COMPLETED     22  
NOT COMPLETED     3  
Lost to Follow-up                 2  
never initiated treatment                 1  



  Baseline Characteristics
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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
  Description
Maraviroc + Darunavir/Ritonavir maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily

Baseline Measures
    Maraviroc + Darunavir/Ritonavir  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Median ( Inter-Quartile Range )
  38  
  ( 31 to 43 )  
Gender  
[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 )
  4.62  
  ( 4.18 to 4.80 )  
[1] Median HIV-1 RNA



  Outcome Measures
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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
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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
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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
e-mail: b-taiwo@northwestern.edu


Publications of Results:

Responsible Party: Babafemi Taiwo, Northwestern University
ClinicalTrials.gov Identifier: NCT00993148     History of Changes
Other Study ID Numbers: MIDAS
Study First Received: October 8, 2009
Results First Received: July 28, 2014
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board