A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

NCT00524368 | Completed Phase 3 Results DMC

• 3 other identifiers: CR013783TMC114-TiDP31-C2292007-001939-61
• Study Type: interventional
• Target: 590
• Locations: 18 countries
• Sites: 83

Brief Summary

The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).

Conditions

Human Immunodeficiency Virus - Type 1

Keywords

Human immunodeficiency virus - type 1; HIV-1 Infection; TMC-114; Darunavir; Ritonavir

Outcome Measures

Primary Outcomes (1)

• Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

  The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.

  48 Weeks

Secondary Outcomes (11)

• Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)

  48 weeks

• Change in log10 Viral Load From Baseline at Week 48

  48 weeks

• Time to Reach First Virologic Response

  48 weeks

• Time to Loss of Virologic Response

  48 weeks

• Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks

  48 weeks

Study Arms (2)

DRV/rtv 800/100 mg once daily

EXPERIMENTAL

Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily.

Drug: Darunavir (DRV); Drug: Ritonavir (rtv)

DRV/rtv 600/100 mg twice daily

EXPERIMENTAL

One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily.

Drug: Darunavir (DRV); Drug: Ritonavir (rtv)

Interventions

Darunavir (DRV) DRUG

DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.

Also known as: TMC114

DRV/rtv 600/100 mg twice daily; DRV/rtv 800/100 mg once daily

Ritonavir (rtv) DRUG

DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.

Also known as: rtv

DRV/rtv 600/100 mg twice daily; DRV/rtv 800/100 mg once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented human immunodeficiency virus - Type 1 (HIV-1) infection
• Patients with a viral load greater than 1,000 HIV-1 ribonucleic acid (RNA) copies/mL
• Stable highly active antiretroviral therapy (HAART) regimen for at least 12 weeks at screening
• In the investigator's opinion, non-nucleoside reverse transcriptase inhibitors (NNRTIs) are not a valid treatment option, because of the patient's antiretroviral (ARV) treatment history, ARV resistance testing, medication-taking behavior, safety and tolerability concerns, or other patient-related factors
• Prescreening or/and screening plasma HIV-1 RNA greater than 1,000 copies/mL on HAART regimen at screening

You may not qualify if:

• Presence of any currently active conditions that fit the definition of the World Health Organization (WHO) Clinical Stage 4, with the following exceptions: stable cutaneous kaposi's sarcoma (ie, no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study time period, wasting syndrome
• Patients for whom an investigational ARV is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval): tenofovir, emtricitabine
• Previous or current use of enfuvirtide (ENF), tipranavir and/or DRV
• Life expectancy of less than 12 months
• Pregnant or breast-feeding females
• Any active clinically significant disease (eg, tuberculosis \[TB\], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (85)

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Oakland, California, United States

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Palm Springs, California, United States

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Fort Lauderdale, Florida, United States

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Fort Laudersale, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Safety Harbor, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Springfield, Massachusetts, United States

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Berkley, Michigan, United States

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Newark, New Jersey, United States

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Albany, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Huntersville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Guernica, Argentina

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Neuquén, Argentina

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Rosario, Argentina

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Darlinghurst, Australia

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Surry Hills, Australia

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Vienna, Austria

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Curitiba, Brazil

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Distrito Barao Geraldo-Campina, Brazil

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Pinheiros, Brazil

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Recife, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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Providencia, Chile

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Santiago, Chile

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Lyon, France

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Nice, France

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Orléans, France

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Paris, France

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Vandœuvre-lès-Nancy, France

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Berlin, Germany

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Cologne, Germany

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München, Germany

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Guatemala City, Guatemala

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Budapest, Hungary

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Ipoh, Malaysia

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Kuala Lumpur, Malaysia

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Pulau Pinang, Malaysia

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Sungai Buloh, Malaysia

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Panama City, Panama

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San Juan, Puerto Rico

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Bucharest, Romania

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Constanța, Romania

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Iași, Romania

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Timișoara, Romania

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Cape Town, South Africa

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Cyrildene Johannesburg Gauteng, South Africa

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Dundee, South Africa

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Durban, South Africa

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Houghton, Johannesburg, South Africa

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Johannesburg, South Africa

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Pretoria, South Africa

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Westdene Johannesburg Gauteng, South Africa

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Barcelona, Spain

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Madrid, Spain

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Kaohsiung County, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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Nonthaburi, Thailand

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London, United Kingdom

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Related Publications (1)

• Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.

  PMID: 23558157 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow 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

Results Point of Contact

• Title: Medical Leader
• Organization: Tibotec Pharmaceuticals, Ireland

+32 015 461 497

Study Officials

• Tibotec Pharmaceuticals, Ireland Clinical Trial

  Tibotec Pharmaceuticals, Ireland

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: September 3, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2011
• Last Updated: February 15, 2013
• Results First Posted: September 22, 2010

Record last verified: 2013-02

Locations

DE (3); PA (1); AU (1); FR (5); MY (4); CL (2); ZA (8); PR (1); GB (1); ES (2); TW (3); GU (1); AR (5); BR (7); HU (1); RO (4); TH (4); US (30)