Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01516970

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

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:
HIV Postexposure Prophylaxis With Darunavir/r (PEPDar)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01516970
Study type Interventional
Source Janssen-Cilag G.m.b.H
Contact
Status Completed
Phase Phase 3
Start date November 2011
Completion date September 2013
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Completed NCT02234492 - The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients Phase 4
Completed NCT01685372 - Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults Phase 2
Completed NCT02027441 - Enhanced Prevention in Couples: Feasibility Study #2 N/A
Completed NCT02165202 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis Phase 2
Completed NCT01615601 - An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients Phase 4
Completed NCT02572401 - Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men N/A
Terminated NCT01448486 - A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV Phase 4
Completed NCT01449006 - A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac) Phase 4
Completed NCT04122404 - POC Strategies to Improve TB Care in Advanced HIV Disease N/A
Completed NCT03290755 - Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
Completed NCT02974998 - Cape Town Young Women's Health CoOp N/A
Completed NCT01997346 - Multi-level Determinants of Starting ART Late: Aim 2 N/A
Active, not recruiting NCT01875952 - Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL) Phase 4
Completed NCT01199939 - A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients Phase 2
Completed NCT03783130 - Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults Phase 1
Active, not recruiting NCT05657106 - Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk N/A
Not yet recruiting NCT05727033 - Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections N/A
Completed NCT01053741 - Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission N/A
Completed NCT02946047 - The Effect of Ixazomib on the Latent HIV Reservoir Phase 1/Phase 2