HIV InfectionPhase 3NCT00110877
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
A Phase 3 study testing LPV/rtv and TMC114/rtv in people with HIV Infection, run by Tibotec Pharmaceuticals, Ireland at 103 sites in 26 countries.
Trial summary
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- LPV/rtv and TMC114/rtv
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 103 sitesin 26 countries
- Study dates
- Apr 2005to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patient has documented HIV-1 infection
- Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
- Plasma HIV-1 RNA >1000 copies/mL
- General medical condition does not interfere with the assessments and the completion of the trial
Who cannot join
- Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
- tenofovir, emtricitabine, atazanavir, fosamprenavir
- Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
- Life expectancy of less than 6 months
- Pregnant or breast-feeding
- Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period
- Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels
- Participation in other investigational trials without prior approval of the sponsor
Trial locations and contacts
103 sites in 26 countries.
103 sites in 26 countries
United States39 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Berkley, Michigan
Study site
Beverly Hills, California
Study site
Boston, Massachusetts
Study site
Camden, New Jersey
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbia, South Carolina
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
East Orange, New Jersey
Study site
Fort Lauderdale, Florida
Study site
Galveston, Texas
Study site
Hampton, Virginia
Study site
Houston, Texas
Study site
Huntersville, North Carolina
Study site
Little Rock, Arkansas
Study site
Long Beach, California
Study site
Longview, Texas
Study site
Los Angeles, California
Study site
Macon, Georgia
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Newark, New Jersey
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Portland, Oregon
Study site
Safety Harbor, Florida
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Tampa, Florida
Study site
The Bronx, New York
Study site
Vero Beach, Florida
Study site
Washington D.C., District of Columbia
Study site
West Hollywood, California
Study site
Winston-Salem, North Carolina
Germany8 sites
Study site
Aachen
Study site
Berlin
Study site
Cologne
Study site
Düsseldorf
Study site
Hamburg
Study site
Mannheim
Study site
Osnabrück
Study site
Stuttgart
Brazil6 sites
Study site
Curitiba
Study site
Distrito Barao Geraldo-Campina
Study site
Nova Iguaçu
Study site
Pinheiros
Study site
Rio de Janeiro
Study site
São Paulo
Russia5 sites
Study site
Kazan'
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Saint Petersburg
Study site
Volgograd
South Africa5 sites
Study site
Cape Town
Study site
Durban
Study site
Houghton, Johannesburg
Study site
Johannesburg
Study site
Pretoria
Australia4 sites
Study site
Darlinghurst
Study site
Melbourne
Study site
Perth
Study site
Surry Hills
Canada4 sites
Study site
Calgary, Alberta
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Toronto, Ontario
France4 sites
Study site
Nice
Study site
Paris
Study site
Rennes
Study site
Villejuif
Argentina3 sites
Study site
Buenos Aires
Study site
Córdoba
Study site
Rosario
Netherlands3 sites
Study site
Amsterdam
Study site
Groningen
Study site
Rotterdam
About this study
Official title: A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.
Read the detailed description
Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.
- Conditions
- HIV Infection
- Being tested
- LPV/rtv, TMC114/rtv
- Keywords
- Human Immunodeficiency Virus, Treatment Experienced, TMC114-C214
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPV/rtvDrug
One 400mg LPV tablet twice daily with 100mg RTV
TMC114/rtvDrug
Two 300mg TMC114 tablets twice daily with 100mg RTV
| Study group | Role | What they receive |
|---|---|---|
| 002 | Experimental | LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV Receives: Drug: LPV/rtv |
| 001 | Experimental | TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV Receives: Drug: TMC114/rtv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)
Measured: 48 weeks
Secondary outcomes (2)
Number of Participants with Adverse Events
Measured: 96 weeks
Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)
Measured: 96 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2007
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110877
- Sponsor's protocol ID
- CR002794
- Other IDs
- TMC114-C214
- Status last verified
- Jul 2015
- First submitted
- 13 May 2005
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Bethune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58. doi: 10.1016/S0140-6736(07)61049-6.
PubMed 17617272Banhegyi D, Katlama C, da Cunha CA, Schneider S, Rachlis A, Workman C, De Meyer S, Vandevoorde A, Van De Casteele T, Tomaka F. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012 Mar;10(2):171-81. doi: 10.2174/157016212799937218.
PubMed 22339125
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00110877
- Acronym / sponsor ID
- CR002794
- Conditions
- HIV Infection
- Keywords
- Human Immunodeficiency Virus, Treatment Experienced, TMC114-C214
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.
Detailed description
Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 002 | Experimental | Drug: LPV/rtvLPV/rtv One 400mg LPV tablet twice daily with 100mg RTV |
| 001 | Experimental | Drug: TMC114/rtvTMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has documented HIV-1 infection
- Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
- Plasma HIV-1 RNA >1000 copies/mL
- General medical condition does not interfere with the assessments and the completion of the trial
Key exclusion criteria (8 listed)
- Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
- tenofovir, emtricitabine, atazanavir, fosamprenavir
- Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
- Life expectancy of less than 6 months
- Pregnant or breast-feeding
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 |
|---|---|---|
| LPV/rtvOne 400mg LPV tablet twice daily with 100mg RTV | Drug | 002 |
| TMC114/rtvTwo 300mg TMC114 tablets twice daily with 100mg RTV | Drug | 001 |
Primary outcome
Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)
Time frame: 48 weeks
2 secondary outcomes
Number of Participants with Adverse Events
Time frame: 96 weeks
Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)
Time frame: 96 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Results publication: PubMed 17617272Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Bethune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58. doi: 10.1016/S0140-6736(07)61049-6.
- Derived from this study: PubMed 22339125Banhegyi D, Katlama C, da Cunha CA, Schneider S, Rachlis A, Workman C, De Meyer S, Vandevoorde A, Van De Casteele T, Tomaka F. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012 Mar;10(2):171-81. doi: 10.2174/157016212799937218.
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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 Clinical Trial study director
Tibotec Pharmaceutical Limited
103 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LPV/rtv and TMC114/rtv in people with HIV Infection, run by Tibotec Pharmaceuticals, Ireland at 103 sites in 26 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 4 inclusion and 8 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Germany, Brazil, Russia, South Africa and 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population) (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 NCT00110877, which also lists 2 linked publications.
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 3 Jul 2015.