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

Human Immunodeficiency Virus (HIV) Clinical Trial

— PEPDar  

Official title:

HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516970
• Other study ID #: CR018349
• Secondary ID: TMC114IDF3004201
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2011
• Last updated: April 9, 2015
• Start date: November 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: Janssen-Cilag G.m.b.H
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag G.m.b.H

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with early discontinuation from randomized human immunodeficiency virus postexposure prophylaxis (HIV PEP)	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 at least 28 days and a maximum of 30 days.	Up to 30 days	Yes
Secondary	Number of patients with Adverse Events as a Measure of tolerability and safety of HIV PEP	Tolerability and safety of HIV PEP.	Up to Month 3	Yes
Secondary	Changes from baseline in Patient reported outcome questionaire	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.	Baseline to Month 3	No
Secondary	Percentage of patients who developed detectable HIV antibodies	Seroconversion rate of HIV antibodies while receiving HIV PEP will be evaluated as the percentage of patients who developed detectable HIV antibodies.	At Month 3	No