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 - Full Text View

Sponsor:	Tibotec Pharmaceuticals, Ireland
Collaborator:	Tibotec Pharmaceutical Limited
Information provided by:	Tibotec Pharmaceuticals, 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:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II, Open Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of DRV/Rtv q.d. in Treatment-na�ve HIV-1 Infected Adolescents Between 12 and < 18 Year of Age

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Darunavir Darunavir ethanolate

U.S. FDA Resources

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:

Virological Response[Viral Load <50 Copies/mL, TLOVR] [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
The analysis is based on virologic response defined as percentage of subjects with confirmed plasma viral load < 50 HIV-1 RNA copies/mL at Week 24 calculated according to the FDA TLOVR algorithm.

Secondary Outcome Measures:

Virological Response[Viral Load <50 Copies/mL, FDA-SNAPSHOT] [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) subjects who had >= 50 copies/mL in the Week-24 window, b) subjects who discontinued prior to Week 24 for lack or loss of efficacy, c) subjects who had a switch in their OBR that was not permitted by the protocol, and d) subjects who discontinued for reasons other than AEs/death, and lack or loss of efficacy (provided their last available viral load was detectable).

Enrollment:	12
Study Start Date:	July 2009
Study Completion Date:	March 2011
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 darunavir tablets 2 x 400 mg tablet once daily for 48 weeks	Drug: darunavir tablets 2 x 400 mg tablet once daily for 48 weeks
Experimental: 002 ritonavir capsule 100 mg capsule once daily for 48 weeks	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

Sponsors and Collaborators

Tibotec Pharmaceuticals, Ireland

Tibotec Pharmaceutical Limited

Investigators

Study Director:

Tibotec Pharmaceuticals Clinical Trial

Tibotec Pharmaceutical Limited

More Information

No publications provided

Responsible Party:	Compound Development Team Leader, Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:	NCT00915655 History of Changes
Other Study ID Numbers:	CR016312, TMC114-TiDP29-C230
Study First Received:	June 4, 2009
Results First Received:	November 25, 2011
Last Updated:	November 25, 2011
Health Authority:	United States: Food and Drug Administration; Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:

HIV Infections
TMC114-TiDP29-C230
TMC114-C230
TMC114

HIV
darunavir
ritonavir

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antiviral Agents

Ritonavir
Darunavir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on February 09, 2012