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TMC114-TiDP29-C230 - A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Adolescents Between 12 and 18 Years of Age Who Have Not Received Previous Treatment With Antiretroviral Drugs
This study is currently recruiting participants.
Verified by Tibotec Pharmaceuticals Limited, Ireland, August 2009
First Received: June 4, 2009   Last Updated: August 19, 2009   History of Changes
Sponsors and Collaborators: Tibotec Pharmaceuticals Limited, Ireland
Tibotec Pharmaceuticals
Information provided by: Tibotec Pharmaceuticals Limited, Ireland
ClinicalTrials.gov Identifier: NCT00915655
  Purpose

The purpose of this Phase II trial is to evaluate pharmacokinetics ( blood levels), safety, tolerability, and efficacy of darunavir with low-dose ritonavir (DRV/rtv) administered once daily (q.d.), in combination with an investigator-selected background regimen consisting of 2 NRTIs, in treatment-naÃ-ve (never treated before) HIV 1 infected adolescents aged from 12 to < 18 years and weighing at least 40 kg


Condition Intervention Phase
HIV Infections
Drug: darunavir tablets
Drug: ritonavir capsule
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title: A Phase II, Open Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of DRV q.d. in Treatment-naïve HIV-1 Infected Adolescents Between 12 and < 18 Year of Age.

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals Limited, Ireland:

Primary Outcome Measures:
  • To evaluate the pharmacokinetics of DRV/rtv 800/100 mg q.d. in combination with an investigator-selected background regimen over a 24-week treatment period in ARV treatment-naÃ-ve HIV-1 infected adolescents from 12 to < 18 years and weighing >=40 kg [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate long-term safety, tolerability and efficacy of DRV/rtv 800/100 mg once daily. (in combination with an investigator-selected background regimen) over a 48-week treatment period in this population. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • To evaluate immunology, resistance characteristics, pharmacokinetics, and pharmacokinetic/pharmacodynamic (PK/PD) relationships over 48 weeks of treatment with DRV/rtv 800/100 mg q.d. in this population. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: July 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: darunavir tablets
2 x 400 mg tablet once daily for 48 weeks
002: Experimental Drug: ritonavir capsule
100 mg capsule once daily for 48 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a documented HIV 1 infection
  • Body weight from at least 40 kg at screening
  • Screening plasma HIV 1 RNA >= 1000 copies/mL
  • Parents or legal representative and trial patients (where appropriate, depending on age and local regulation) willing and able to give consent and assent
  • General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial
  • Able to swallow DRV tablets (400 mg) and ritonavir capsules (100 mg)

Exclusion Criteria:

  • Patients with presence of any currently active conditions included in the listing of WHO (World Health Organisation) Clinical Stage 4
  • Any condition (including, but not limited to, alcohol and drug use), which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol
  • Previous or current use of ARVs ( antiretrovirals)
  • Primary or acute HIV infection
  • Use of any investigational agents within 30 days prior to screening
  • Use of disallowed concomitant therapy
  • Pregnant or breast-feeding
  • Female patient of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
  • Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation (i.e., liver insufficiency), irrespective of liver enzyme levels
  • Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the patient's safety or outcome in the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915655

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

Locations
United States, Tennessee
Recruiting
Memphis, Tennessee, United States
France
Not yet recruiting
Paris, France
Ireland
Not yet recruiting
Dublin, Ireland
Spain
Not yet recruiting
Madrid, Spain
Not yet recruiting
Esplugues De Llobregat, Spain
Ukraine
Not yet recruiting
Kiev, Ukraine
United Kingdom
Not yet recruiting
Bristol, United Kingdom
Not yet recruiting
Birmingham, United Kingdom
Not yet recruiting
Stoke On Trent, United Kingdom
Sponsors and Collaborators
Tibotec Pharmaceuticals Limited, Ireland
Tibotec Pharmaceuticals
Investigators
Study Director: Tibotec Pharmaceuticals Limited Clinical Trial Tibotec Pharmaceutical Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Tibotec Pharmaceuticals Limited, Ireland ( Compound Development Team Leader )
Study ID Numbers: CR016312, TMC114-TiDP29-C230
Study First Received: June 4, 2009
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00915655     History of Changes
Health Authority: United States: Food and Drug Administration;   Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals Limited, Ireland:
TMC114-TiDP29-C230
TMC114-C230
TMC114
HIV
darunavir
ritonavir

Study placed in the following topic categories:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Darunavir
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

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

ClinicalTrials.gov processed this record on September 03, 2009