Phase 3
Completed N=590
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)
Human Immunodeficiency Virus - Type 1
Source: ClinicalTrials.gov NCT00524368 ↗
Enrolled (actual)
590
Serious AEs
7.3%
Results posted
Sep 2010
Primary outcomePrimary: 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 — 212; 210 Participants — p=<0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
212; 210 | <0.001 sig |
| SECONDARY Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) |
226; 227 | <0.001 sig |
| SECONDARY Change in log10 Viral Load From Baseline at Week 48 |
4.23; 4.134; -2.11; -2.13 | 0.977 |
| SECONDARY Time to Reach First Virologic Response |
85; 85 | 0.917 |
| SECONDARY Time to Loss of Virologic Response |
250.235; 281.743 | 0.716 |
| SECONDARY Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks |
-1.77; -1.74 | 0.711 |
| SECONDARY Change in CD4+ Cell Count From Baseline |
219; 236; 100; 94 | 0.562 |
| SECONDARY Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score |
129; 123.5; 2.5; 0.0 | 0.761 |
| SECONDARY Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 |
67.4; 60.3; 32.6; 39.7 | — |
| SECONDARY Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv |
87788; 109401; 5776; 12588 | — |
| SECONDARY Predose Plasma Concentration (C0h) of DRV and Rtv. |
1896; 3197; 59; 307 | — |
| SECONDARY Number of Participants Developing Mutations at Endpoint |
1; 0; 1; 0; 7; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00524368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.