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

PHASE3CompletedINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

November 25, 2011

Primary Completion Date

August 1, 2013

Study Completion Date

September 28, 2013

Conditions
Human Immunodeficiency Virus (HIV)
Interventions
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.

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.

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.

DRUG

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.

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.

Trial Locations (17)

Unknown

Berlin

Bonn

Cologne

Dortmund

Dresden

Düsseldorf

Erlangen

Frankfurt

Freiburg im Breisgau

Hamburg

Magdeburg

Mainz

Mannheim

München

Regensburg

Stuttgart

Ulm

All Listed Sponsors
lead

Janssen-Cilag G.m.b.H

INDUSTRY

NCT01516970 - Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) | Biotech Hunter | Biotech Hunter