HIV postexposure prophylaxis with Darunavir/r (PEPDar)

• Conditions: HIV postexposure prophylaxis; MedDRA version: 14.1Level: PTClassification code 10054925Term: Prophylaxis against HIV infectionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-001303-13-DE
• Lead Sponsor: Janssen Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-07
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•Man or woman greater than 18 years of age.
•Occupational injury or non ocupational injury with documented HIV exposure, or potential for HIV exposure.
•Indication for HIV PEP, as determined by the treating physician and/or the investigator.
•If standard of care HIV PEP was initiated prior to screening, this should have occurred no more than 72 hours after injury and no more than 36 hours before screening.
•If standard of care HIV PEP is to be initiated after screening, this should occur no more than 72 hours after injury.
•Women must be:
•postmenopausal (for at least 2 years),
•surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
•abstinent (at the discretion of the investigator/per local regulations), or
•if sexually active, be practicing a highly effective method of birth control assuring a Pearl-Index below 1 (before entry, and must agree to continue to use the same method of contraception throughout the study. Women using oral contraceptives must agree to use an additional birth control method.
•Women of childbearing potential must have a negative urine pregnancy test at screening.
•Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
•Willing to continue HIV PEP for at least 28 days and maximum of 30 days.
•Willing/able to adhere to the prohibitions and restrictions specified in this protocol.
•Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 318
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•Positive HIV rapid test.
•History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, GI, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
•Results of the serum chemistry panel, hematology, or urinalysis measurements at screening (which may only be available after screening) are outside the normal reference ranges, and the investigator judges the abnormalities or deviations from normal to be clinically significant or not appropriate and reasonable for the population under study. This determination must be recorded in the subject’s source documents and initialed by the investigator.
Note: Because this study is conducted in an emergency setting, some or all of the laboratory results may not be available at the time of randomization, but subjects can still be enrolled and randomized in the absence of this information. Laboratory results that become available after randomization must be checked immediately after receipt and if this exclusion criterion is then met, subjects must be withdrawn from the study afterwards.

•Contraindication for any component of the DRV/r PEP or standard of care PEP.
•Known allergies, hypersensitivity, or intolerance to the active pharmaceutical ingredients or any excipients (refer to Section 14.1, Physical Description of Study Drug[s]) of the DRV/r PEP or standard of care PEP, or to sulfonamides.
•Received an investigational drug (including vaccines) or used an investigational medical device within 1 month before the start of treatment or are currently enrolled in an investigational study.
•Pregnant or breast-feeding.
•Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the rate of early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in subjects receiving HIV PEP for at least 28 days and maximum 30 days.;Secondary Objective: To evaluate:<br>•Tolerability and safety of HIV PEP.<br>•Patient reported outcome (PRO) assessment of functional impairment in conjunction with HIV PEP in 3 inter-related domains (work, social life, and family life), as calculated from subject responses to the Sheehan Disability Scale (SDS) questionnaire.<br>;Primary end point(s): - to assess the rate of early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in subjects receiving HIV PEP for at least 28 days and maximum 30 days<br>;Timepoint(s) of evaluation of this end point: 21 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - to evaluate:<br>•Tolerability and safety of HIV PEP.<br>•Patient reported outcome (PRO) assessment of subject wellbeing and HIV PEP tolerability, as calculated from subject responses to SDS (Sheehan Disability Scale) questionnaire.<br>;Timepoint(s) of evaluation of this end point: 21 month