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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Human Immunodeficiency Virus (HIV)

Treatments: Drug: Darunavir/Ritonavir (DRV/r); Drug: NRTIs; Drug: Lopinavir in fixed combination with Ritonavir; Drug: Zidovudine; Drug: Efavirenz

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516970

TMC114IFD3004 (Other Identifier)

2011-001303-13 (EudraCT Number)

CR018349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

DRV/r with 2 NRTIs

Experimental group

Description:

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).

Treatment:

Drug: NRTIs

Drug: Darunavir/Ritonavir (DRV/r)

Comparator standard of care HIV PEP

Active Comparator group

Description:

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.

Treatment:

Drug: Efavirenz

Drug: Zidovudine

Drug: Lopinavir in fixed combination with Ritonavir

Drug: NRTIs