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

NCT01615601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2014-05-22

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

DRUG

darunavir (PREZISTA)

Form = tablet, route = oral, Units = mg, number = 800 administered once daily

DRUG

etravirine (INTELENCE)

Form = tablet, route = oral, Unit = mg, number = 200, administered twice daily

DRUG

ritonavir

Form = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily

DRUG

Other antiretroviral medications

Given as per Canadian Product Monograph

Sponsors & Collaborators

  • Janssen Inc.

    lead INDUSTRY

Principal Investigators

  • Janssen Inc. Clinical Trial · Janssen Inc.

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615601 on ClinicalTrials.gov