Human Immunodeficiency Virus - Type 1Phase 3ODINNCT00524368
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)
A Phase 3 study testing Darunavir (DRV) and Ritonavir (rtv) in people with Human Immunodeficiency Virus - Type 1, run by Tibotec Pharmaceuticals, Ireland at 85 sites in 19 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus - Type 1
- What is being tested?
- Darunavir (DRV) and Ritonavir (rtv)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 85 sitesin 19 countries
- Study dates
- Oct 2007to Oct 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
85 sites in 19 countries.
85 sites in 19 countries
United States30 sites
Study site
Akron, Ohio
Study site
Albany, New York
Study site
Atlanta, Georgia
Study site
Berkley, Michigan
Study site
Beverly Hills, California
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Fort Lauderdale, Florida
Study site
Fort Laudersale, Florida
Study site
Harlingen, Texas
Study site
Houston, Texas
Study site
Huntersville, North Carolina
Study site
Little Rock, Arkansas
Study site
Macon, Georgia
Study site
Miami, Florida
Study site
Miami Beach, Florida
Study site
New York, New York
Study site
Newark, New Jersey
Study site
Oakland, California
Study site
Orlando, Florida
Study site
Palm Springs, California
Study site
Phoenix, Arizona
Study site
Rochester, New York
Study site
Safety Harbor, Florida
Study site
Savannah, Georgia
Study site
Springfield, Massachusetts
Study site
The Bronx, New York
Study site
West Palm Beach, Florida
Study site
Winston-Salem, North Carolina
South Africa8 sites
Study site
Cape Town
Study site
Cyrildene Johannesburg Gauteng
Study site
Dundee
Study site
Durban
Study site
Houghton, Johannesburg
Study site
Johannesburg
Study site
Pretoria
Study site
Westdene Johannesburg Gauteng
Brazil7 sites
Study site
Curitiba
Study site
Distrito Barao Geraldo-Campina
Study site
Pinheiros
Study site
Recife
Study site
Rio de Janeiro
Study site
Salvador
Study site
São Paulo
Argentina5 sites
Study site
Buenos Aires
Study site
Córdoba
Study site
Guernica
Study site
Neuquén
Study site
Rosario
France5 sites
Study site
Lyon
Study site
Nice
Study site
Orléans
Study site
Paris
Study site
Vandœuvre-lès-Nancy
Malaysia4 sites
Study site
Ipoh
Study site
Kuala Lumpur
Study site
Pulau Pinang
Study site
Sungai Buloh
Romania4 sites
Study site
Bucharest
Study site
Constanța
Study site
Iași
Study site
Timișoara
Thailand4 sites
Study site
Bangkok
Study site
Chiang Mai
Study site
Khon Kaen
Study site
Nonthaburi
About this study
Official 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
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).
Read the detailed description
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) selected by the investigator. The study will include a 4 week screening period, 48-weeks of treatment period and 4-weeks of follow-up. The study will also consists of extension phase after Week 48: in regions where DRV is not yet commercially available or reimbursed by the health care system, patients who complete the 48 weeks of treatment with DRV/rtv and who continue to benefit from this treatment, will have the opportunity to continue DRV treatment as a 600 mg twice daily dosage until DRV is reimbursed and available via the public and/or private health care system or until its development is discontinued. Safety evaluation will consists of adverse events (including specific toxicities), clinical laboratory tests, vital signs, electrocardiogram, physical and skin examination.
- Conditions
- Human Immunodeficiency Virus - Type 1
- Being tested
- Darunavir (DRV), Ritonavir (rtv)
- Keywords
- Human immunodeficiency virus - type 1, HIV-1 Infection, TMC-114, Darunavir, Ritonavir
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir (DRV)Drug
Also called TMC114
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.
Ritonavir (rtv)Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| DRV/rtv 800/100 mg once daily | Experimental | Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily. Receives: Drug: Darunavir (DRV); Drug: Ritonavir (rtv) |
| DRV/rtv 600/100 mg twice daily | Experimental | One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily. Receives: Drug: Darunavir (DRV); Drug: Ritonavir (rtv) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 Weeks
Secondary outcomes (11)
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.
Measured: 48 weeks
Change in log10 Viral Load From Baseline at Week 48
Measured: 48 weeks
Time to Reach First Virologic Response
Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.
Measured: 48 weeks
Time to Loss of Virologic Response
Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.
Measured: 48 weeks
Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks
Measured: 48 weeks
Change in CD4+ Cell Count From Baseline
CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.
Measured: 48 Weeks
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.
Measured: 48 weeks
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.
Measured: 48 weeks
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.
Measured: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.
Predose Plasma Concentration (C0h) of DRV and Rtv.
Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.
Measured: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48
Number of Participants Developing Mutations at Endpoint
Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus - Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals, Ireland Clinical Trial, Study director, Tibotec Pharmaceuticals, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524368
- Sponsor's protocol ID
- CR013783
- Other IDs
- TMC114-TiDP31-C229, 2007-001939-61
- Acronym
- ODIN
- Status last verified
- Feb 2013
- First submitted
- 30 Aug 2007
- Last updated
- 15 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.
PubMed 23558157
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00524368
- Acronym / sponsor ID
- ODIN / CR013783
- Conditions
- Human Immunodeficiency Virus - Type 1
- Keywords
- Human immunodeficiency virus - type 1, HIV-1 Infection, TMC-114, Darunavir, Ritonavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 22 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) selected by the investigator. The study will include a 4 week screening period, 48-weeks of treatment period and 4-weeks of follow-up. The study will also consists of extension phase after Week 48: in regions where DRV is not yet commercially available or reimbursed by the health care system, patients who complete the 48 weeks of treatment with DRV/rtv and who continue to benefit from this treatment, will have the opportunity to continue DRV treatment as a 600 mg twice daily dosage until DRV is reimbursed and available via the public and/or private health care system or until its development is discontinued. Safety evaluation will consists of adverse events (including specific toxicities), clinical laboratory tests, vital signs, electrocardiogram, physical and skin examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRV/rtv 800/100 mg once daily | Experimental | Drug: Darunavir (DRV), Drug: Ritonavir (rtv)Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily. |
| DRV/rtv 600/100 mg twice daily | Experimental | Drug: Darunavir (DRV), Drug: Ritonavir (rtv)One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darunavir (DRV)Also: TMC114DRV/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. | Drug | DRV/rtv 600/100 mg twice daily, DRV/rtv 800/100 mg once daily |
| Ritonavir (rtv)Also: rtvDRV/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. | Drug | DRV/rtv 600/100 mg twice daily, DRV/rtv 800/100 mg once daily |
Primary outcome
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
Time frame: 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.
11 secondary outcomes
Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)
Time frame: 48 weeks
Change in log10 Viral Load From Baseline at Week 48
Time frame: 48 weeks
Time to Reach First Virologic Response
Time frame: 48 weeks
Time to Loss of Virologic Response
Time frame: 48 weeks
Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks
Time frame: 48 weeks
Change in CD4+ Cell Count From Baseline
Time frame: 48 Weeks
Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score
Time frame: 48 weeks
Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48
Time frame: 48 weeks
Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv
Time frame: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.
Predose Plasma Concentration (C0h) of DRV and Rtv.
Time frame: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48
Number of Participants Developing Mutations at Endpoint
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23558157Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec Pharmaceuticals, Ireland Clinical Trial study director
Tibotec Pharmaceuticals, Ireland
85 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darunavir (DRV) and Ritonavir (rtv) in people with Human Immunodeficiency Virus - Type 1, run by Tibotec Pharmaceuticals, Ireland at 85 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, South Africa, Brazil, Argentina, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.