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Comparison · NCT00524368-66e55d36

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

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 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, record NCT00524368-66e55d36. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00524368-66e55d36

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.7210.6670.769wilson
Risk in group 20.7090.6550.758wilson
Risk difference, group 1 minus group 20.0116-0.0610.0841newcombe hybrid score
Risk ratio, group 1 over group 21.020.9181.13log
Odds ratio, group 1 over group 21.060.741.51log
Number needed to treat, for one more participant with the outcome on DRV/Rtv 800/100 mg Once Daily than on DRV/Rtv 600/100 mg Twice Daily86from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1DRV/Rtv 800/100 mg Once DailyTwo 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily212294OG000
Group 2DRV/Rtv 600/100 mg Twice DailyOne 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily210296OG001

Outcome

Type
PRIMARY
Title
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
Description
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.
Time frame
48 Weeks
Population
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.

Source ClinicalTrials.gov

Trial

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
Phases
PHASE3
Conditions
Human Immunodeficiency Virus - Type 1
Interventions
Darunavir (DRV), Ritonavir (rtv)
Lead sponsor
Tibotec Pharmaceuticals, Ireland
Results first posted
2010-09-22

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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