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

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ClinicalTrials.gov Identifier: NCT01726348
Recruitment Status : Withdrawn (The company decided to cancel this study in conformity with PH FDA Circular 2013-004)
First Posted : November 14, 2012
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus-Type 1 Drug: No intervention

Detailed Description:
This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), uncontrolled (all the patients receiving darunavir) clinical and observational study (study in which the investigators/physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type 1 (HIV-1) infection among adult Filipino patients. The study will enroll 10 percentage of patient who would use the product, as a requirement of the Philippine Food and Drug Administration (FDA). Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The duration of treatment will be for 24 weeks and the total study will be conducted for 3 years.

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Darunavir
Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.
 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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients with incidence of adverse events [ Time Frame: Up to 24 weeks ]
  2. Number of patients with incidence of discontinuation of study medication due to adverse events [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Mean decrease of viral load at the end of treatment from baseline [ Time Frame: Baseline, Week 12, and Week 24 ]
  2. Number of patients with viral load of 50 copies per ml at the end of treatment [ Time Frame: Baseline, Week 12, and Week 24 ]
  3. Number of patients with lack of effect [ Time Frame: Up to 24 weeks ]
    Any failure of expected pharmacologic action of the study medication


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include adult Filipino patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment.
Criteria

Inclusion Criteria:

  • Patients who are diagnosed with human immunodeficiency virus-type 1 (HIV-1), and who are eligible for darunavir (in combination with ritonavir) treatment. These may be either: treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions; or treatment-experienced adult patients with at least one darunavir resistance associated substitution

Exclusion Criteria:

  • Known hypersensitivity to darunavir/ritonavir or to any of the components of the two agent preparations
  • Pregnant or breastfeeding females
  • Agrees to protocol-defined use of effective contraception
  • Patients taking medication that are highly dependent on Cytochrome P450 3A4 for clearance and for which initial concentrations are associated with serious and/or life threatening events
  • Patients with severe hepatic impairment
  • History of allergy to sulfa containing drugs or molecules
  • Patients currently receiving alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonavine, cisapride, pimozide, midazolam, triazolam, St. John's Wort (Hypericum perforatum), lovastatin, simvastatin, rifampin and sildenafil
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726348


Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01726348     History of Changes
Other Study ID Numbers: CR014686
TMC114HIV4013 ( Other Identifier: Janssen Pharmaceutica )
PRE-PHL-MA1 ( Other Identifier: Janssen Pharmaceutica )
TMC-C-07-PH-007 ( Other Identifier: Janssen Pharmaceutica )
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Janssen Pharmaceutica:
Human Immunodeficiency Virus-Type 1
HIV-1
TMC114
 Darunavir
Ritonavir
Filipino

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
 Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors