MedTrace Logo

A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients

NCT01726348 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-12-02

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.

Conditions

  • Human Immunodeficiency Virus-Type 1

Interventions

DRUG

No intervention

This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks. For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food. For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.

Sponsors & Collaborators

  • Janssen Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica Clinical Trial · Janssen Pharmaceutica

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

More Related Trials

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 NCT01726348 on ClinicalTrials.gov