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

This study has been withdrawn prior to enrollment.
(The company decided to cancel this study in conformity with PH FDA Circular 2013-004)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01726348
First received: November 9, 2012
Last updated: June 18, 2013
Last verified: June 2013

November 9, 2012
June 18, 2013
January 2014
December 2014   (final data collection date for primary outcome measure)
  • Number of patients with incidence of adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with incidence of discontinuation of study medication due to adverse events [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01726348 on ClinicalTrials.gov Archive Site
  • Mean decrease of viral load at the end of treatment from baseline [ Time Frame: Baseline, Week 12, and Week 24 ] [ Designated as safety issue: No ]
  • Number of patients with viral load of 50 copies per ml at the end of treatment [ Time Frame: Baseline, Week 12, and Week 24 ] [ Designated as safety issue: No ]
  • Number of patients with lack of effect [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Any failure of expected pharmacologic action of the study medication
Same as current
Not Provided
Not Provided
 
A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients
A Post-Marketing Surveillance Study on the Safety and Effectiveness of Darunavir on Filipino Patients With Human Immunodeficiency Virus-Type I (HIV-1) Infection

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Human Immunodeficiency Virus-Type 1
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.
Darunavir
Patients will be taking darunavir as per the dosing regimen given on product insert approved in Philippines.
Intervention: Drug: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01726348
CR014686, TMC114HIV4013, PRE-PHL-MA1, TMC-C-07-PH-007
No
Janssen Pharmaceutica
Janssen Pharmaceutica
Not Provided
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
Janssen Pharmaceutica
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP