Trial · NCT00524368
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, Phase 3, Completed, Tibotec Pharmaceuticals, Ireland; results first posted 2010-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT00524368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00524368
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT00524368
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 590 participants, actual
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Conditions
- Human Immunodeficiency Virus - Type 1
- Interventions
- Darunavir (DRV), Ritonavir (rtv)
- First posted
- 2007-09-03
- Last updated
- 2013-02-15
- Other registries' IDs
- eudract:2007-001939-61
- Results first posted
- 2010-09-22
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 48 Weeks | 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. |
| Secondary | Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | 48 weeks | Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48. |
| Secondary | Change in log10 Viral Load From Baseline at Week 48 | 48 weeks | |
| Secondary | Time to Reach First Virologic Response | 48 weeks | Time (in weeks) to achieve viral load less than 50 copies/mL by the participants. |
| Secondary | Time to Loss of Virologic Response | 48 weeks | Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants. |
| Secondary | Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | 48 weeks | |
| Secondary | Change in CD4+ Cell Count From Baseline | 48 Weeks | CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm. |
| Secondary | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | 48 weeks | The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening. |
| Secondary | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | 48 weeks | Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days. |
| Secondary | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48. | Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 48 Weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Participants | NUMBER |
| SECONDARY | Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Participants | NUMBER |
| SECONDARY | Change in log10 Viral Load From Baseline at Week 48 | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | log10 copies/mL | MEDIAN |
| SECONDARY | Time to Reach First Virologic Response | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Days | MEDIAN |
| SECONDARY | Time to Loss of Virologic Response | 48 weeks | Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse. | Days | MEAN |
| SECONDARY | Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks | 48 weeks | Intention To Treat (ITT) population: Observed cases | log10 copies/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in CD4+ Cell Count From Baseline | 48 Weeks | Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation. | 10e6/l | MEDIAN |
| SECONDARY | Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score | 48 weeks | Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation. | Scores on a scale | MEDIAN |
| SECONDARY | Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 | 48 weeks | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv | 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48. | Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication. | ng*h/mL | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | DRV/Rtv 800/100 mg Once Daily | 212 | Participants | ||
| 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 | DRV/Rtv 600/100 mg Twice Daily | 210 | Participants | ||
| Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | DRV/Rtv 800/100 mg Once Daily | 226 | Participants | ||
| Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | DRV/Rtv 600/100 mg Twice Daily | 227 | Participants | ||
| Change in log10 Viral Load From Baseline at Week 48 | DRV/Rtv 800/100 mg Once Daily | Log10 Viral Load at baseline | 4.23 | Full Range 1.73 to 6.43 | log10 copies/mL |
| Change in log10 Viral Load From Baseline at Week 48 | DRV/Rtv 600/100 mg Twice Daily | Log10 Viral Load at baseline | 4.134 | Full Range 1.69 to 5.98 | log10 copies/mL |
| Change in log10 Viral Load From Baseline at Week 48 | DRV/Rtv 800/100 mg Once Daily | Log10 Viral Load change from baseline at Week 48 | -2.11 | Full Range -4.7 to 2.0 | log10 copies/mL |
| Change in log10 Viral Load From Baseline at Week 48 | DRV/Rtv 600/100 mg Twice Daily | Log10 Viral Load change from baseline at Week 48 | -2.13 | Full Range -4.2 to 2.4 | log10 copies/mL |
| Time to Reach First Virologic Response | DRV/Rtv 800/100 mg Once Daily | 85 | Full Range 71 to 86 | Days | |
| Time to Reach First Virologic Response | DRV/Rtv 600/100 mg Twice Daily | 85 | Full Range 83 to 85 | Days |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DRV/Rtv 800/100 mg Once Daily | 294 | |
| Overall Study | STARTED | DRV/Rtv 600/100 mg Twice Daily | 296 | |
| Overall Study | COMPLETED | DRV/Rtv 800/100 mg Once Daily | 253 | |
| Overall Study | COMPLETED | DRV/Rtv 600/100 mg Twice Daily | 248 | |
| Overall Study | NOT COMPLETED | DRV/Rtv 800/100 mg Once Daily | 41 | |
| Overall Study | NOT COMPLETED | DRV/Rtv 600/100 mg Twice Daily | 48 |
Source ClinicalTrials.gov
Adverse events148
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | DRV/Rtv 800/100 mg Once Daily | 42 | 294 | |
| other | Diarrhoea | Gastrointestinal disorders | DRV/Rtv 600/100 mg Twice Daily | 66 | 296 | |
| other | Nausea | Gastrointestinal disorders | DRV/Rtv 800/100 mg Once Daily | 38 | 294 | |
| other | Nausea | Gastrointestinal disorders | DRV/Rtv 600/100 mg Twice Daily | 42 | 296 | |
| other | Vomiting | Gastrointestinal disorders | DRV/Rtv 800/100 mg Once Daily | 13 | 294 | |
| other | Vomiting | Gastrointestinal disorders | DRV/Rtv 600/100 mg Twice Daily | 25 | 296 | |
| other | Nasopharyngitis | Infections and infestations | DRV/Rtv 800/100 mg Once Daily | 19 | 294 | |
| other | Nasopharyngitis | Infections and infestations | DRV/Rtv 600/100 mg Twice Daily | 19 | 296 | |
| other | Influenza | Infections and infestations | DRV/Rtv 800/100 mg Once Daily | 17 | 294 | |
| other | Influenza | Infections and infestations | DRV/Rtv 600/100 mg Twice Daily | 18 | 296 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DRV/Rtv 800/100 mg Once Daily | ||
| Total, all-cause mortality | DRV/Rtv 600/100 mg Twice Daily | ||
| Total, other adverse events | DRV/Rtv 800/100 mg Once Daily | 134 | 294 |
| Total, other adverse events | DRV/Rtv 600/100 mg Twice Daily | 147 | 296 |
| Total, serious adverse events | DRV/Rtv 800/100 mg Once Daily | 16 | 294 |
| Total, serious adverse events | DRV/Rtv 600/100 mg Twice Daily | 27 | 296 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23558157 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
DRV/Rtv 800/100 mg Once Daily vs DRV/Rtv 600/100 mg Twice Daily: 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 | Trial comparisons |
| DRV/Rtv 800/100 mg Once Daily vs DRV/Rtv 600/100 mg Twice Daily: Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) | Trial comparisons |
| DRV/Rtv 800/100 mg Once Daily vs DRV/Rtv 600/100 mg Twice Daily: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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