A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents

NCT00915655 | Completed Phase 2 Results DMC

• 3 other identifiers: CR016312TMC114-TiDP29-C2302008-004631-37
• Study Type: interventional
• Target: 12
• Locations: 6 countries
• Sites: 9

Brief Summary

The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected adolescents aged from 12 to \<18 years and weighing at least 40 kg.

Conditions

HIV-1 Infection

Keywords

HIV Infections; TMC114-TiDP29-C230; TMC114-C230; TMC114; HIV-1; Darunavir; Ritonavir; NRTI; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Virological Response[Viral Load <50 Copies/mL, TLOVR]

  The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load \<50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.

  Week 24

Secondary Outcomes (1)

• Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]

  Week 24

Study Arms (1)

DRV/rtv (darunavir/ritonavir)

EXPERIMENTAL

Patients will receive darunavir tablets 2 x 400 mg in combination with ritonavir capsule 100 mg once daily for 48 weeks along with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) ie, either zidovudine/lamivudine or abacavir/lamivudine

Drug: darunavir; Drug: ritonavir; Drug: zidovudine; Drug: lamivudine; Drug: abacavir

Interventions

darunavir DRUG

Type=exact number, unit=mg, number=400, formulation=tablet, route=oral. 2 tablets of darunavir administered once daily for 48 weeks

Also known as: DRV

DRV/rtv (darunavir/ritonavir)

ritonavir DRUG

Type=exact number, unit=mg, number=100, formulation=capsule, route=oral. 1 capsule of ritonavir administered once daily for 48 weeks

Also known as: rtv

DRV/rtv (darunavir/ritonavir)

zidovudine DRUG

NRTI (zidovudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country

DRV/rtv (darunavir/ritonavir)

lamivudine DRUG

NRTI (lamivudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country

DRV/rtv (darunavir/ritonavir)

abacavir DRUG

NRTI (abacavir) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country

DRV/rtv (darunavir/ritonavir)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 darunavir tablets (400 mg) and ritonavir capsules (100 mg)

You may not qualify if:

• Patients with presence of any currently active conditions included in the listing of World Health Organisation (WHO) Clinical Stage 4
• Any condition (including, but not limited to, alcohol and drug use), which, in the opinion of the investigator, could compromise the patient's safety or adherence to the trial protocol
• Previous or current use of antiretrovirals (ARVs)
• 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 (ie, liver insufficiency), irrespective of liver enzyme levels
• Any active clinically significant disease (eg, 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (9)

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Esplugues de Llobregat, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Kiev, Ukraine

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Bristol, United Kingdom

Location

Unknown Facility

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir; Ritonavir; Zidovudine; Lamivudine; abacavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine

Results Point of Contact

• Title: Medical Leader
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

+1 609 730-7548

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 8, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 3, 2012
• Results First Posted: December 28, 2011

Record last verified: 2012-08

Locations

GB (3); FR (1); IE (1); US (1); ES (2); UA (1)