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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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United States of America
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Arkansas
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California
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Florida
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Georgia
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Illinois
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Massachusetts
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Michigan
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New Jersey
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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
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Texas
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Argentina
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Buenos Aires
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Argentina
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Cordoba
Country [17] 0 0
Argentina
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Guernica
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Argentina
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Neuquen
Country [19] 0 0
Argentina
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Rosario
Country [20] 0 0
Austria
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Wien
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Brazil
State/province [21] 0 0
Curitiba
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Brazil
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Distrito Barao Geraldo-Campina
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Brazil
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Pinheiros
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Brazil
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Recife
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Brazil
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Rio De Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Chile
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Providencia
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Chile
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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
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Paris Cedex 10
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France
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Paris Cedex 12
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France
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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
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Guatemala
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Hungary
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Budapest
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Malaysia
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Ipoh
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Malaysia
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Sungai Buloh
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Panama
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Panama
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Constanta
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Romania
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Iasi
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Romania
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Timisoara
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South Africa
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Cape Town
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South Africa
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Cyrildene Johannesburg Gauteng
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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
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South Africa
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Johannesburg
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South Africa
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Pretoria
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South Africa
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Westdene Johannesburg Gauteng
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Spain
State/province [60] 0 0
Barcelona N/A
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Spain
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Madrid
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Taiwan
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Kaohsiung County
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Taiwan
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Taichung 407
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Taiwan
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Taipei
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Thailand
State/province [65] 0 0
Bangkok
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Thailand
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Chiang Mai
Country [67] 0 0
Thailand
State/province [67] 0 0
Khon Kaen
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Thailand
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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
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00524368
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00524368