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A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855335
First Posted: March 4, 2009
Last Update Posted: November 7, 2017
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.
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
Results First Submitted: June 30, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Pregnancy
Interventions: Drug: Darunavir
Drug: Ritonavir
Drug: Etravirine
Drug: Rilpivirine
Drug: Darunavir/Cobicistat (FDC)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Slow recruitment led to enrollment hold on 5th arm (Darunavir800 mg/Cobicistat150 mg) in 2016. In March 2017, agreement reached with EU regulatory authority to combine the 5tharm data with another study. Database lock and data analysis of 5th arm were therefore not available within 1 year of end of trial; results will be submitted by Dec2017.

Reporting Groups
  Description
Darunavir 600 mg /Ritonavir 100 mg Twice Daily Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Darunavir 800 mg /Ritonavir 100 mg Once Daily Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Etravirine 200 mg Twice Daily Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
Rilpivirine 25 mg Once Daily Participants were receiving tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily from prior to the study as per routine clinical practice up to at least 12 weeks postpartum.

Participant Flow:   Overall Study
    Darunavir 600 mg /Ritonavir 100 mg Twice Daily   Darunavir 800 mg /Ritonavir 100 mg Once Daily   Etravirine 200 mg Twice Daily   Rilpivirine 25 mg Once Daily
STARTED   17   17   15   19 
COMPLETED   12   15   10   12 
NOT COMPLETED   5   2   5   7 
Lost to Follow-up                0                0                3                1 
Withdrawal by Subject                0                0                0                1 
Adverse Event                2                0                0                0 
Physician Decision                1                1                0                0 
Other                2                1                2                5 



  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
Darunavir 600 mg /Ritonavir 100 mg Twice Daily Participants received darunavir 600 milligram (mg) tablets (300*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.
Darunavir 800 mg /Ritonavir 100 mg Once Daily Participants received darunavir 800 mg tablets (400*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.
Etravirine 200 mg Twice Daily Participants received etravirine 200 mg (100*2) tablets orally twice daily up to 12 weeks postpartum.
Rilpivirine 25 mg Once Daily Participants were receiving tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily from prior to the study as per routine clinical practice up to at least 12 weeks postpartum.
Total Total of all reporting groups

Baseline Measures
   Darunavir 600 mg /Ritonavir 100 mg Twice Daily   Darunavir 800 mg /Ritonavir 100 mg Once Daily   Etravirine 200 mg Twice Daily   Rilpivirine 25 mg Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   15   19   68 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.7  (5.77)   24.1  (3.55)   26.3  (4.91)   27.2  (4.51)   25.8  (4.77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      17 100.0%      17 100.0%      15 100.0%      19 100.0%      68 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   17   17   15   19   68 


  Outcome Measures
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1.  Primary:   Predose (Trough) Plasma Concentration (C0h)   [ Time Frame: Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8) ]

2.  Primary:   Minimum Plasma Concentration (Cmin)   [ Time Frame: Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8) ]

3.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8) ]

4.  Primary:   Time to Reach the Maximum Plasma Concentration (Tmax)   [ Time Frame: Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8) ]

5.  Primary:   Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)   [ Time Frame: Predose, 1, 2, 3, 4, 6, 9, 12 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8) ]

6.  Primary:   Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)   [ Time Frame: Predose, 1, 2, 3, 4, 6, 9, 12, and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8) ]

7.  Secondary:   Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)   [ Time Frame: Up to postpartum (6-12 weeks) ]

8.  Secondary:   Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value   [ Time Frame: Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks) ]

9.  Secondary:   Mean Change From Baseline in CD4+ Cell Count   [ Time Frame: Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks) ]

10.  Secondary:   Number of Participants With Resistance at Virological Failure   [ Time Frame: Up to follow-up phase (16 weeks after postpartum) ]

11.  Secondary:   Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery   [ Time Frame: On day of delivery - Intrapartum (Visit 6) ]

12.  Secondary:   Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result   [ Time Frame: Birth to age 16 weeks ]

13.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to follow up period (16 weeks after postpartum) ]


  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 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Leader, Medical Department
Organization: Janssen Scientific Affairs, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00855335     History of Changes
Other Study ID Numbers: CR015442
TMC114HIV3015 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: March 2, 2009
First Posted: March 4, 2009
Results First Submitted: June 30, 2017
Results First Posted: September 15, 2017
Last Update Posted: November 7, 2017