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)

NCT ID: NCT00524368

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 590 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-10-31

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).

Detailed Description

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) selected by the investigator. The study will include a 4 week screening period, 48-weeks of treatment period and 4-weeks of follow-up. The study will also consists of extension phase after Week 48: in regions where DRV is not yet commercially available or reimbursed by the health care system, patients who complete the 48 weeks of treatment with DRV/rtv and who continue to benefit from this treatment, will have the opportunity to continue DRV treatment as a 600 mg twice daily dosage until DRV is reimbursed and available via the public and/or private health care system or until its development is discontinued. Safety evaluation will consists of adverse events (including specific toxicities), clinical laboratory tests, vital signs, electrocardiogram, physical and skin examination.

Conditions

Human Immunodeficiency Virus - Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DRV/rtv 800/100 mg once daily

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

Group Type: EXPERIMENTAL

Darunavir (DRV)

Intervention Type: 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.

Ritonavir (rtv)

Intervention Type: 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.

DRV/rtv 600/100 mg twice daily

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

Group Type: EXPERIMENTAL

Darunavir (DRV)

Intervention Type: 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.

Ritonavir (rtv)

Intervention Type: 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.

Interventions

Darunavir (DRV)

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.

Intervention Type: DRUG

Ritonavir (rtv)

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.

Intervention Type: DRUG

Other Intervention Names

TMC114; rtv

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibotec Pharmaceuticals, Ireland Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceuticals, Ireland

Locations

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Beverly Hills, California, United States

Oakland, California, United States

Palm Springs, California, United States

Fort Lauderdale, Florida, United States

Fort Laudersale, Florida, United States

Miami, Florida, United States

Miami Beach, Florida, United States

Orlando, Florida, United States

Safety Harbor, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Macon, Georgia, United States

Savannah, Georgia, United States

Chicago, Illinois, United States

Springfield, Massachusetts, United States

Berkley, Michigan, United States

Newark, New Jersey, United States

Albany, New York, United States

New York, New York, United States

Rochester, New York, United States

The Bronx, New York, United States

Huntersville, North Carolina, United States

Winston-Salem, North Carolina, United States

Akron, Ohio, United States

Charleston, South Carolina, United States

Dallas, Texas, United States

Harlingen, Texas, United States

Houston, Texas, United States

Buenos Aires, , Argentina

Córdoba, , Argentina

Guernica, , Argentina

Neuquén, , Argentina

Rosario, , Argentina

Darlinghurst, , Australia

Surry Hills, , Australia

Vienna, , Austria

Curitiba, , Brazil

Distrito Barao Geraldo-Campina, , Brazil

Pinheiros, , Brazil

Recife, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

São Paulo, , Brazil

Providencia, , Chile

Santiago, , Chile

Lyon, , France

Nice, , France

Orléans, , France

Paris, , France

Vandœuvre-lès-Nancy, , France

Berlin, , Germany

Cologne, , Germany

München, , Germany

Guatemala City, , Guatemala

Budapest, , Hungary

Ipoh, , Malaysia

Kuala Lumpur, , Malaysia

Pulau Pinang, , Malaysia

Sungai Buloh, , Malaysia

Panama City, , Panama

San Juan, , Puerto Rico

Bucharest, , Romania

Constanța, , Romania

Iași, , Romania

Timișoara, , Romania

Cape Town, , South Africa

Cyrildene Johannesburg Gauteng, , South Africa

Dundee, , South Africa

Durban, , South Africa

Houghton, Johannesburg, , South Africa

Johannesburg, , South Africa

Pretoria, , South Africa

Westdene Johannesburg Gauteng, , South Africa

Barcelona, , Spain

Madrid, , Spain

Kaohsiung County, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Bangkok, , Thailand

Chiang Mai, , Thailand

Khon Kaen, , Thailand

Nonthaburi, , Thailand

London, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Brazil; Chile; France; Germany; Guatemala; Hungary; Malaysia; Panama; Puerto Rico; Romania; South Africa; Spain; Taiwan; Thailand; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23558157 (View on PubMed)

Other Identifiers

TMC114-TiDP31-C229

Identifier Type: OTHER

Identifier Source: secondary_id

2007-001939-61

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR013783

Identifier Type: -

Identifier Source: org_study_id

NCT00613990

Identifier Type: -

Identifier Source: nct_alias