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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00524368




Registration number
NCT00524368
Ethics application status
Date submitted
30/08/2007
Date registered
3/09/2007
Date last updated
15/02/2013

Titles & IDs
Public 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)
Scientific title
A Randomized, Open-label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-experienced HIV-1 Infected Subjects
Secondary ID [1] 0 0
TMC114-TiDP31-C229
Secondary ID [2] 0 0
CR013783
Universal Trial Number (UTN)
Trial acronym
ODIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus - Type 1 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darunavir (DRV)
Treatment: Drugs - Ritonavir (rtv)

Experimental: DRV/rtv 800/100 mg once daily - Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily.

Experimental: DRV/rtv 600/100 mg twice daily - One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily.


Treatment: Drugs: Darunavir (DRV)
DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.

Treatment: Drugs: Ritonavir (rtv)
DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
48 Weeks
Secondary outcome [1] 0 0
Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Change in log10 Viral Load From Baseline at Week 48
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Time to Reach First Virologic Response
Timepoint [3] 0 0
48 weeks
Secondary outcome [4] 0 0
Time to Loss of Virologic Response
Timepoint [4] 0 0
48 weeks
Secondary outcome [5] 0 0
Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks
Timepoint [5] 0 0
48 weeks
Secondary outcome [6] 0 0
Change in CD4+ Cell Count From Baseline
Timepoint [6] 0 0
48 Weeks
Secondary outcome [7] 0 0
Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score
Timepoint [7] 0 0
48 weeks
Secondary outcome [8] 0 0
Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48
Timepoint [8] 0 0
48 weeks
Secondary outcome [9] 0 0
Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv
Timepoint [9] 0 0
0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.
Secondary outcome [10] 0 0
Predose Plasma Concentration (C0h) of DRV and Rtv.
Timepoint [10] 0 0
0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48
Secondary outcome [11] 0 0
Number of Participants Developing Mutations at Endpoint
Timepoint [11] 0 0
48 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
590
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Surry Hills
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Surry Hills
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Argentina
State/province [17] 0 0
Guernica
Country [18] 0 0
Argentina
State/province [18] 0 0
Neuquen
Country [19] 0 0
Argentina
State/province [19] 0 0
Rosario
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Brazil
State/province [21] 0 0
Curitiba
Country [22] 0 0
Brazil
State/province [22] 0 0
Distrito Barao Geraldo-Campina
Country [23] 0 0
Brazil
State/province [23] 0 0
Pinheiros
Country [24] 0 0
Brazil
State/province [24] 0 0
Recife
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio De Janeiro
Country [26] 0 0
Brazil
State/province [26] 0 0
Salvador
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Chile
State/province [28] 0 0
Providencia
Country [29] 0 0
Chile
State/province [29] 0 0
Santiago
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France
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Lyon
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France
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Nice
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France
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Orleans Cedex 2
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France
State/province [33] 0 0
Paris Cedex 10
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France
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Paris Cedex 12
Country [35] 0 0
France
State/province [35] 0 0
Paris
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Germany
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Köln
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Germany
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München
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Guatemala
State/province [40] 0 0
Guatemala
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Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Malaysia
State/province [42] 0 0
Ipoh
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Malaysia
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Kuala Lumpur
Country [44] 0 0
Malaysia
State/province [44] 0 0
Pulau Pinang
Country [45] 0 0
Malaysia
State/province [45] 0 0
Sungai Buloh
Country [46] 0 0
Panama
State/province [46] 0 0
Panama
Country [47] 0 0
Puerto Rico
State/province [47] 0 0
San Juan
Country [48] 0 0
Romania
State/province [48] 0 0
Bucuresti
Country [49] 0 0
Romania
State/province [49] 0 0
Constanta
Country [50] 0 0
Romania
State/province [50] 0 0
Iasi
Country [51] 0 0
Romania
State/province [51] 0 0
Timisoara
Country [52] 0 0
South Africa
State/province [52] 0 0
Cape Town
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South Africa
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Cyrildene Johannesburg Gauteng
Country [54] 0 0
South Africa
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Dundee
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South Africa
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Durban
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South Africa
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Houghton, Johannesburg
Country [57] 0 0
South Africa
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Johannesburg
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South Africa
State/province [58] 0 0
Pretoria
Country [59] 0 0
South Africa
State/province [59] 0 0
Westdene Johannesburg Gauteng
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona N/A
Country [61] 0 0
Spain
State/province [61] 0 0
Madrid
Country [62] 0 0
Taiwan
State/province [62] 0 0
Kaohsiung County
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taichung 407
Country [64] 0 0
Taiwan
State/province [64] 0 0
Taipei
Country [65] 0 0
Thailand
State/province [65] 0 0
Bangkok
Country [66] 0 0
Thailand
State/province [66] 0 0
Chiang Mai
Country [67] 0 0
Thailand
State/province [67] 0 0
Khon Kaen
Country [68] 0 0
Thailand
State/province [68] 0 0
Nonthaburi
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tibotec Pharmaceuticals, Ireland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tibotec Pharmaceuticals, Ireland Clinical Trial
Address 0 0
Tibotec Pharmaceuticals, Ireland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00524368