Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) (PEPDar)
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ClinicalTrials.gov Identifier: NCT01516970 |
Recruitment Status
:
Completed
First Posted
: January 25, 2012
Results First Posted
: October 11, 2016
Last Update Posted
: July 19, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Actual Enrollment : | 312 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | HIV Postexposure Prophylaxis With Darunavir/r (PEPDar) |
Actual Study Start Date : | November 25, 2011 |
Actual Primary Completion Date : | August 1, 2013 |
Actual Study Completion Date : | September 28, 2013 |

Arm | Intervention/treatment |
---|---|
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).
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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.
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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.
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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
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- Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP) [ Time Frame: Up to 30 days ]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.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Month 3 ]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 ]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 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516970
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 |
Study Director: | Janssen-Cilag G.m.b.H, Germany Clinical Trial | Janssen-Cilag G.m.b.H |
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 ) |
First Posted: | January 25, 2012 Key Record Dates |
Results First Posted: | October 11, 2016 |
Last Update Posted: | July 19, 2017 |
Last Verified: | June 2017 |
Studies a U.S. FDA-regulated Device Product: | No |
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 |