CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 312 enrolled
Drug / intervention
Darunavir/Ritonavir (DRV/r) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01516970
NCT01516970Phase 3Completed
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HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)

Janssen-Cilag G.m.b.H·interventional·Posted Jan 25, 2012·Updated Jul 19, 2017

In Brief

A Phase 3 clinical trial evaluating Darunavir/Ritonavir (DRV/r), Lopinavir in fixed combination with Ritonavir, and 3 other interventions for Human Immunodeficiency Virus (HIV). Completed, enrolled 312 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus (HIV)
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartNov 25, 2011
Primary CompletionAug 1, 2013
Study CompletionSep 28, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.4 years ago

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.

Lopinavir in fixed combination with Ritonavirdrug

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.

Zidovudinedrug

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.

NRTIsdrug

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.

Efavirenzdrug

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.