Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) (PEPDar)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT01516970
First received: October 11, 2011
Last updated: August 16, 2016
Last verified: August 2016
Results First Received: June 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus (HIV)
Interventions: Drug: Darunavir/Ritonavir (DRV/r)
Drug: Lopinavir in fixed combination with Ritonavir
Drug: Zidovudine
Drug: NRTIs
Drug: Efavirenz

  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
No text entered.

Reporting Groups
  Description
Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP) Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
Standard of Care Postexposure Prophylaxis (SOCPEP) Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.

Participant Flow:   Overall Study
    Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)   Standard of Care Postexposure Prophylaxis (SOCPEP)
STARTED   159   153 
COMPLETED   141   132 
NOT COMPLETED   18   21 
Lost to Follow-up                7                8 
Adverse Event                1                5 
Withdrawal by Subject                1                1 
Unspecified                9                7 



  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.
The safety population included all participants who received at least 1 dose of randomized HIV PEP.

Reporting Groups
  Description
Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP) Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
Standard of Care Postexposure Prophylaxis (SOCPEP) Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
Total Total of all reporting groups

Baseline Measures
   Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)   Standard of Care Postexposure Prophylaxis (SOCPEP)   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   153   312 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.2  (9.2)   32.3  (9.3)   33.3  (9.3) 
Gender 
[Units: Participants]
     
Female   28   28   56 
Male   131   125   256 


  Outcome Measures
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1.  Primary:   Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)   [ Time Frame: Up to 30 days ]

2.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: Up to Month 3 ]

3.  Secondary:   Worst Sheehan Disability Scale (SDS) Score for the Safety Population   [ Time Frame: Month 3 ]

4.  Secondary:   Percentage of Participants Who Developed Detectable HIV Antibodies   [ Time Frame: At Month 3 ]


  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-Cilag GmbH
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT01516970     History of Changes
Other Study ID Numbers: CR018349
TMC114IFD3004 ( Other Identifier: Janssen-Cilag G.m.b.H, Germany )
2011-001303-13 ( EudraCT Number )
Study First Received: October 11, 2011
Results First Received: June 20, 2016
Last Updated: August 16, 2016