Overview

An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients

Status:
Completed

Trial end date:
2013-04-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate tolerability of darunavir (PREZISTA) or etravirine (INTELENCE) in patients infected with human immunodeficiency virus type 1 (HIV-1) who are naïve to these medications and in patients who have experienced tolerability issues on their current or prior combination antiretroviral therapy (cART). The tolerability is evaluated by switching the patients from their previous or current combination antiretroviral therapy (cART) to either darunavir or etravirine.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Janssen Inc.

Treatments:

Anti-Retroviral Agents
Darunavir
Etravirine
Ritonavir

Criteria

Inclusion Criteria:

- Have a documented HIV-1 infection

- Have 1 or more significant symptoms with at least grade 2 toxicity on the Division of
AIDS Toxicity "DAIDS grading scale" on current or prior combination antiretroviral
therapy (cART) regimen (current or prior cART including regimens consisting of 2
Nucleoside reverse transcriptase inhibitors (NRTIs) and a third agent with the
exception of darunavir or etravirine)

- Have stable response to current cART ie, have an HIV-plasma viral load [number of
virus in blood] at screening <400 copies/mL (undetectable) or last plasma viral load
on prior regimen within the previous 6 months <400 copies/mL)

- Must not have resistance to Primary HIV protease inhibitor medicines

Exclusion Criteria:

- Has been Infected with HIV-2 - Has received previous treatment with darunavir or
etravirine or non-HAART (Highly Active Antiretroviral Therapy) regimen

- Has had prior virologic failure to 2 or more regimens or single virologic failure on
prior cART

- Has a documented resistance to darunavir and etravirine

- Is currently using any drug contraindicated in the current Canadian Product Monograph
for darunavir or etravirine