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

Purpose

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	Intervention	Phase
Human Immunodeficiency Virus-Type 1	Drug: No intervention	Phase 4


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Darunavir Darunavir ethanolate

U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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


Enrollment:	0
Study Start Date:	January 2014
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726348

Sponsors and Collaborators

Janssen Pharmaceutica

Investigators


Study Director:	Janssen Pharmaceutica Clinical Trial	Janssen Pharmaceutica

More Information


Responsible Party:	Janssen Pharmaceutica
ClinicalTrials.gov Identifier:	NCT01726348 History of Changes
Other Study ID Numbers:	CR014686 TMC114HIV4013 PRE-PHL-MA1 TMC-C-07-PH-007
Study First Received:	November 9, 2012
Last Updated:	November 30, 2015
Health Authority:	Philippine: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016