Clinical trial NCT01516970: Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
Official title: HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: Human Immunodeficiency Virus (HIV) Post exposure prophylaxis
DRV/r
Occupational injury
Non-occupational exposure
Prezista
Darunavir/r
Lead sponsor: Janssen-Cilag G.m.b.H
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)
timeFrame: Up to 30 days
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Month 3
measure: Worst Sheehan Disability Scale (SDS) Score for the Safety Population
timeFrame: Month 3
measure: Percentage of Participants Who Developed Detectable HIV Antibodies
timeFrame: At Month 3
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Köln
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Regensburg
country: Germany
city: Stuttgart
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: Janssen-Cilag G.m.b.H
name: Janssen-Cilag G.m.b.H, Germany Clinical Trial
role: STUDY_DIRECTOR
References: