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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
  Purpose
The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV infection status of the index person in patients receiving HIV PEP for at least 28 and a maximum of 30 days.

Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
Drug: Darunavir/Ritonavir (DRV/r)
Drug: Lopinavir in fixed combination with Ritonavir
Drug: Zidovudine
Drug: NRTIs
Drug: Efavirenz
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag G.m.b.H:

Primary Outcome Measures:
  • Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP) [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT [defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person]) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.


Secondary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Month 3 ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined to be non-treatment-emergent if the onset date of the AE was clearly before the date of first HIV PEP administration, otherwise it is considered treatment-emergent.

  • Worst Sheehan Disability Scale (SDS) Score for the Safety Population [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    The Sheehan Disability Scale (SDS) assesses functional impairment in 3 inter-related domains: work/school, social and family life, using a rating scale for each item ranging from 0 (not at all) to 10 (extremely).

  • Percentage of Participants Who Developed Detectable HIV Antibodies [ Time Frame: At Month 3 ] [ Designated as safety issue: No ]
    Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies (defined as positive) and percentage of participants who had not developed detectable HIV antibodies (defined as negative). Per protocol (PP) population included all participants in mITT (defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.


Enrollment: 312
Study Start Date: November 2011
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DRV/r with 2 NRTIs
DRV/r 800/100 mg q.d. with 2 NRTIs: darunavir (800 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).
Drug: Darunavir/Ritonavir (DRV/r)
Darunavir (DRV) type=exact number, unit=mg, number=800, form=tablet, route=oral use. Tablet is taken once a day, for 28 days; Ritonavir (r) type=exact number, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.
Drug: NRTIs
The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) will be administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
Active Comparator: Comparator standard of care HIV PEP
Comparator standard of care HIV PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner.
Drug: Lopinavir in fixed combination with Ritonavir
type=exact number, unit=mg, number=400/100, form=tablet, route=oral use. Tablet is taken once or twice a day, for at least 28 days and a maximum of 30 days.
Other Name: Kaletra
Drug: Zidovudine
type=exact number, unit=mg, number=250, form=tablet, route=oral use. Tablet is taken twice a day, for at least 28 days and a maximum of 30 days.
Other Name: Retrovir
Drug: NRTIs
The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) will be administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
Drug: Efavirenz
type=exact number, unit=mg, number=600, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.
Other Name: Sustiva

Detailed Description:
This is a randomized (study medication assigned by chance), open-label (all people involved know the identity of the intervention), active-controlled (patients are assigned to either a recognized effective treatment or the study medication), parallel-group (each treatment group will be treated at the same time), multicenter study comparing DRV/r PEP (DRV/r administered with 2 NRTIs selected at the discretion of the investigator) to standard of care PEP (as per German-Austrian guidelines) in patients at risk of HIV infection due to HIV exposure through occupational injury and non-occupational exposure. This study consists of screening period, treatment period and a follow up period. HIV PEP will be administered for a total of at least 28 days and maximum of 30 days during treatment period, including any prestudy HIV PEP initiated before screening. Approximately 318 patients will be screened and enrolled to ensure that at least 131 patients are randomly assigned to receive DRV/r PEP or standard of care PEP. Safety will be evaluated during the entire study period. Data relating to a patient's functional impairment in conjunction with HIV PEP will be collected on Day 1 as baseline data, and further on Days 14 and 28 as well as at Month 3.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Occupational injury and non-occupational exposure with documented human immunodeficiency virus (HIV) exposure, or potential for HIV exposure
  • Indication for HIV postexposure prophylaxis (PEP), as determined by the treating physician and/or the investigator
  • Women must be: postmenopausal (for at least 2 years), surgically sterile, using oral contraceptives
  • Willing to continue HIV PEP for 28 days

Exclusion Criteria:

  • Positive HIV rapid test
  • History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastro intestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Pregnant or breast-feeding
  • Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516970

Locations
Germany
Berlin, Germany
Bonn, Germany
Dortmund, Germany
Dresden, Germany
Düsseldorf, Germany
Erlangen, Germany
Frankfurt, Germany
Freiburg, Germany
Hamburg, Germany
Köln, Germany
Magdeburg, Germany
Mainz, Germany
Mannheim, Germany
München, Germany
Regensburg, Germany
Stuttgart, Germany
Ulm, Germany
Sponsors and Collaborators
Janssen-Cilag G.m.b.H
Investigators
Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial Janssen-Cilag G.m.b.H
  More Information

Responsible Party: Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier: NCT01516970     History of Changes
Other Study ID Numbers: CR018349  TMC114IFD3004  2011-001303-13 
Study First Received: October 11, 2011
Results First Received: June 20, 2016
Last Updated: August 16, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by Janssen-Cilag G.m.b.H:
Human Immunodeficiency Virus (HIV) Post exposure prophylaxis
DRV/r
Occupational injury
Non-occupational exposure
Prezista
Darunavir/r

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Darunavir
Zidovudine
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016