Clinical Trial: Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)

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 Summary: 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.
Sponsor: Janssen-Cilag G.m.b.H

Current Primary Outcome: 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.


Original Primary Outcome: Number of patients with early discontinuation from randomized HIV PEP [ Time Frame: After 3 months ]

Number of patients with 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 28 days.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Number of patients with Adverse Events as a Measure of tolerability and safety of HIV PEP [ Time Frame: Baseline; day 14; day 28; month 3 ]
    Tolerability and safety of HIV PEP.
  • Changes from baseline in Patient reported outcome questionaire [ Time Frame: Baseline; day 14; day 28; month 3 ]
    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.
  • Seroconversion rate of HIV antibodies during HIV PEP [ Time Frame: After 3 months ]
  • Number of patients who adhered to HIV PEP [ Time Frame: After 28 days ]
    Adherence to HIV PEP


Information By: Janssen-Cilag G.m.b.H

Dates:
Date Received: October 11, 2011
Date Started: November 2011
Date Completion:
Last Updated: August 16, 2016
Last Verified: August 2016