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)

Completed · Phase 3

Conditions studied: Human Immunodeficiency Virus - Type 1

In brief

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).

Key facts

Study ID

NCT00524368

Run by

Tibotec Pharmaceuticals, Ireland

People needed

590

Starts

2007-10-01

Expected to finish

2011-10-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Oakland, California, United States
• Study site — Palm Springs, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Laudersale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Safety Harbor, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Berkley, Michigan, United States
• Study site — Newark, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Huntersville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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