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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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.
Timepoint [1] 0 0
48 Weeks
Secondary outcome [1] 0 0
Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL) - Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.
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 - Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.
Timepoint [3] 0 0
48 weeks
Secondary outcome [4] 0 0
Time to Loss of Virologic Response - Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.
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 - CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.
Timepoint [6] 0 0
48 Weeks
Secondary outcome [7] 0 0
Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score - 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.
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 - 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.
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 - 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.
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. - Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.
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 - Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [3] 0 0
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
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
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
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Nice
Country [32] 0 0
France
State/province [32] 0 0
Orleans Cedex 2
Country [33] 0 0
France
State/province [33] 0 0
Paris Cedex 10
Country [34] 0 0
France
State/province [34] 0 0
Paris Cedex 12
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Vandoeuvre Les Nancy
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
Köln
Country [39] 0 0
Germany
State/province [39] 0 0
München
Country [40] 0 0
Guatemala
State/province [40] 0 0
Guatemala
Country [41] 0 0
Hungary
State/province [41] 0 0
Budapest
Country [42] 0 0
Malaysia
State/province [42] 0 0
Ipoh
Country [43] 0 0
Malaysia
State/province [43] 0 0
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
Country [53] 0 0
South Africa
State/province [53] 0 0
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
State/province [57] 0 0
Johannesburg
Country [58] 0 0
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
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/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
Other publications