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)

Tibotec Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Human Immunodeficiency Virus - Type 1

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00524368

2007-001939-61 (EudraCT Number)

TMC114-TiDP31-C229 (Other Identifier)

CR013783

Details and patient eligibility

About

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).

Full 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.

Enrollment: 590 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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590 participants in 2 patient groups

DRV/rtv 800/100 mg once daily

Experimental group

Description:

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

Treatment:

Drug: Darunavir (DRV)

Drug: Ritonavir (rtv)

DRV/rtv 600/100 mg twice daily

Experimental group

Description:

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

Treatment:

Drug: Darunavir (DRV)

Drug: Ritonavir (rtv)