A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients (INROADS)

This study has been completed.
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc
ClinicalTrials.gov Identifier:
NCT01199939
First received: September 9, 2010
Last updated: October 4, 2013
Last verified: October 2013
Results First Received: October 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus (HIV)
Interventions: Drug: Etravirine
Drug: Ritonavir
Drug: Darunavir

  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
The study was conducted between 29 March 2010 and 5 October 2012 and recruited patients from US (17 sites) and Puerto Rico (1 site).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
54 participants were treated with Etravirine and Darunavir/ritonavir in this study.

Reporting Groups
  Description
ETR + DRV/Rtv Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks

Participant Flow:   Overall Study
    ETR + DRV/Rtv  
STARTED     54 [1]
COMPLETED     41  
NOT COMPLETED     13  
Adverse Event                 4  
Protocol Violation                 3  
Lost to Follow-up                 2  
Reached a virologic endpoint                 4  
[1] Number of enrolled participants



  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.
No text entered.

Reporting Groups
  Description
ETR + DRV/Rtv Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks

Baseline Measures
    ETR + DRV/Rtv  
Number of Participants  
[units: participants]
  54  
Age  
[units: years]
Mean ± Standard Deviation
  44.4  ± 12.82  
Gender  
[units: participants]
 
Female     12  
Male     42  
Region of Enrollment  
[units: participants]
 
Puerto Rico     4  
USA     50  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Confirmed Virologic Response (CVR) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 4   [ Time Frame: Baseline (Day 1) and Week 4 ]

3.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 8   [ Time Frame: Baseline (Day 1) and Week 8 ]

4.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 12   [ Time Frame: Baseline (Day 1) and Week 12 ]

5.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 16   [ Time Frame: Baseline (Day 1) and Week 16 ]

6.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 20   [ Time Frame: Baseline (Day 1) and Week 20 ]

7.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 24   [ Time Frame: Baseline (Day 1) and Week 24 ]

8.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 30   [ Time Frame: Baseline (Day 1) and Week 30 ]

9.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 36   [ Time Frame: Baseline (Day 1) and Week 36 ]

10.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 42   [ Time Frame: Baseline (Day 1) and Week 42 ]

11.  Secondary:   Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

12.  Secondary:   Time to Reach First Confirmed Virologic Response   [ Time Frame: Baseline (Day 1) to Week 48 ]

13.  Secondary:   Number of Participants With Virologic Failure   [ Time Frame: Baseline (Day 1) to Week 48 ]

14.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4+) and Cluster of Differentiation 8 (CD8+) Cell Counts at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: SENIOR MEDICAL DIRECTOR
Organization: Janssen Pharmaceuticals
phone: 1 609 730-2931


No publications provided


Responsible Party: Tibotec, Inc
ClinicalTrials.gov Identifier: NCT01199939     History of Changes
Other Study ID Numbers: CR017149, TMC125HIV4007
Study First Received: September 9, 2010
Results First Received: October 4, 2013
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration
Puerto Rico: Food and Drug Administration