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

NCT01516970 | Completed Phase 3 Results

• 3 other identifiers: CR018349TMC114IFD30042011-001303-13
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 17

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.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Human Immunodeficiency Virus (HIV) Post exposure prophylaxis; DRV/r; Occupational injury; Non-occupational exposure; Prezista; Darunavir/r

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)

  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.

  Up to 30 days

Secondary Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Up to Month 3

• Worst Sheehan Disability Scale (SDS) Score for the Safety Population

  Month 3

• Percentage of Participants Who Developed Detectable HIV Antibodies

  At Month 3

Study Arms (2)

DRV/r with 2 NRTIs

EXPERIMENTAL

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).

Drug: Darunavir/Ritonavir (DRV/r); Drug: NRTIs

Comparator standard of care HIV PEP

ACTIVE COMPARATOR

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.

Drug: Lopinavir in fixed combination with Ritonavir; Drug: Zidovudine; Drug: NRTIs; Drug: Efavirenz

Interventions

Darunavir/Ritonavir (DRV/r) DRUG

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.

DRV/r with 2 NRTIs

Lopinavir in fixed combination with Ritonavir DRUG

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.

Also known as: Kaletra

Comparator standard of care HIV PEP

Zidovudine DRUG

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.

Also known as: Retrovir

Comparator standard of care HIV PEP

NRTIs DRUG

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.

Comparator standard of care HIV PEP; DRV/r with 2 NRTIs

Efavirenz DRUG

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.

Also known as: Sustiva

Comparator standard of care HIV PEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag G.m.b.H: lead

Study Sites (17)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Dortmund, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Magdeburg, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Regensburg, Germany

Location

Unknown Facility

Stuttgart, Germany

Location

Unknown Facility

Ulm, Germany

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Occupational Injuries

Interventions

Darunavir; Ritonavir; Lopinavir; lopinavir-ritonavir drug combination; Zidovudine; efavirenz

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Pyrimidinones; Pyrimidines; Thymidine; Pyrimidine Nucleosides; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Leader, Medical Department
• Organization: Janssen-Cilag GmbH

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen-Cilag G.m.b.H, Germany Clinical Trial

  Janssen-Cilag G.m.b.H

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: January 25, 2012
• Study Start: November 25, 2011
• Primary Completion: August 1, 2013
• Study Completion: September 28, 2013
• Last Updated: July 19, 2017
• Results First Posted: October 11, 2016

Record last verified: 2017-06

Locations

DE (17)