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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag G.m.b.H
ClinicalTrials.gov Identifier:
NCT01516970
First received: October 11, 2011
Last updated: March 10, 2014
Last verified: March 2014

October 11, 2011
March 10, 2014
November 2011
September 2013   (final data collection date for primary outcome measure)
Number of patients with early discontinuation from randomized human immunodeficiency virus postexposure prophylaxis (HIV PEP) [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
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.
Number of patients with early discontinuation from randomized HIV PEP [ Time Frame: After 3 months ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01516970 on ClinicalTrials.gov Archive Site
  • Number of patients with Adverse Events as a Measure of tolerability and safety of HIV PEP [ Time Frame: Up to Month 3 ] [ Designated as safety issue: Yes ]
    Tolerability and safety of HIV PEP.
  • Changes from baseline in Patient reported outcome questionaire [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]
    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.
  • Percentage of patients who developed detectable HIV antibodies [ Time Frame: At Month 3 ] [ Designated as safety issue: No ]
    Seroconversion rate of HIV antibodies while receiving HIV PEP will be evaluated as the percentage of patients who developed detectable HIV antibodies.
  • 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 ] [ Designated as safety issue: Yes ]
    Tolerability and safety of HIV PEP.
  • Changes from baseline in Patient reported outcome questionaire [ Time Frame: Baseline; day 14; day 28; month 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of patients who adhered to HIV PEP [ Time Frame: After 28 days ] [ Designated as safety issue: No ]
    Adherence to HIV PEP
Not Provided
Not Provided
 
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus (HIV)
  • 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.
    Other Name: Darunavir/Ritonavir (DRV/r)
  • Drug: 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.
    Other Name: Lopinavir in fixed combination with Ritonavir
  • Drug: 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.
    Other Name: Zidovudine
  • Drug: Tenofovir
    type=exact number, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.
    Other Name: Tenofovir
  • Drug: 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.
    Other Name: Efavirenz
  • Experimental: DRV/r with 2 NRTIs
    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).
    Intervention: Drug: Darunavir/Ritonavir (DRV/r)
  • Active Comparator: Comparator standard of care HIV PEP
    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.
    Interventions:
    • Drug: Lopinavir in fixed combination with Ritonavir
    • Drug: Zidovudine
    • Drug: Tenofovir
    • Drug: Efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01516970
CR018349, TMC114IDF3004, 2011-001303-13
No
Janssen-Cilag G.m.b.H
Janssen-Cilag G.m.b.H
Not Provided
Study Director: Janssen-Cilag G.m.b.H, Germany Clinical Trial Janssen-Cilag G.m.b.H
Janssen-Cilag G.m.b.H
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP