HIV InfectionPhase 2NCT00081588
An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
A Phase 2 study testing TMC114 in people with HIV Infection, run by Tibotec Pharmaceuticals, Ireland at 64 sites in 13 countries.
Trial summary
The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time. 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?
- TMC114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 64 sitesin 13 countries
- Study dates
- Nov 2003to Dec 2008
- Phase
- Phase 2
- 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
- Previous participation in the TMC114-C202 or TMC114-C213 trials
- Significant virologic failure during participation in the above trials
- Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
- Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
- Patient has given informed consent
Who cannot join
- Use of disallowed concomitant therapy
- Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
- Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
- Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
- Patient withdrawing consent from TMC114-C202 or TMC114-C213
Trial locations and contacts
64 sites in 13 countries.
64 sites in 13 countries
United States26 sites
Study site
Albany, New York
Study site
Atlanta, Georgia
Study site
Beverly Hills, California
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Camden, New Jersey
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
Fort Lauderdale, Florida
Study site
Galveston, Texas
Study site
Hershey, Pennsylvania
Study site
La Jolla, California
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Macon, Georgia
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
New York, New York
Study site
Oakland, California
Study site
Philadelphia, Pennsylvania
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Springfield, Massachusetts
Study site
Vero Beach, Florida
Study site
Washington D.C., District of Columbia
Germany9 sites
Study site
Berlin
Study site
Bonn
Study site
Düsseldorf
Study site
Essen
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Kÿln
Study site
Mannheim
Study site
Munich
France6 sites
Study site
Le Kremlin-Bicêtre
Study site
Montpellier
Study site
Nantes
Study site
Paris
Study site
Toulon
Study site
Villejuif
Brazil4 sites
Study site
Campinas
Study site
Curitiba
Study site
Rio de Janeiro
Study site
São Paulo
Australia3 sites
Study site
Darlinghurst
Study site
Melbourne
Study site
Perth
Canada3 sites
Study site
Calgary, Alberta
Study site
Montreal, Quebec
Study site
Toronto, Ontario
Spain3 sites
Study site
Barakaldo Vizcaya S/N
Study site
Barcelona
Study site
Madrid
United Kingdom3 sites
Study site
Edinburgh
Study site
London
Study site
Manchester
About this study
The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.
Read the detailed description
The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks.
- Conditions
- HIV Infection
- Being tested
- TMC114
- Keywords
- TMC114-C215, Ritonavir, HIV infections, TMC114-C202, TMC114-C213
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC114Drug
600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available Receives: Drug: TMC114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline.
Measured: 24 weeks
Secondary outcomes (1)
Proportion of patients with a virologic response; with plasma HIV-1 RNA levels < 50 copies/mL; with plasma HIV-1 RNA levels < 400 copies/mL; Time to loss of virologic response over 144 week treatment period; Change in plasma viral load at all time points
Measured: 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2004 (estimated)
- Study startNov 2003
- Primary completionSep 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 555 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
- NCT00081588
- Sponsor's protocol ID
- CR006724
- Other IDs
- TMC114-C215
- Status last verified
- Jun 2014
- First submitted
- 15 Apr 2004
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Molina JM, Cohen C, Katlama C, Grinsztejn B, Timerman A, Pedro Rde J, Vangeneugden T, Miralles D, Meyer SD, Parys W, Lefebvre E; TMC114-C208 Study Group; TMC114-C215 Study Group. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31. doi: 10.1097/QAI.0b013e3181359cfb.
PubMed 17621237
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
- ClinicalTrials.gov ID
- NCT00081588
- Acronym / sponsor ID
- CR006724
- Conditions
- HIV Infection
- Keywords
- TMC114-C215, Ritonavir, HIV infections, TMC114-C202, TMC114-C213
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Apr 2004 (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.
The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.
Detailed description
The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC114TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous participation in the TMC114-C202 or TMC114-C213 trials
- Significant virologic failure during participation in the above trials
- Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
- Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
- Patient has given informed consent
Key exclusion criteria (5 listed)
- Use of disallowed concomitant therapy
- Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
- Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
- Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
- Patient withdrawing consent from TMC114-C202 or TMC114-C213
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 |
|---|---|---|
| TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available | Drug | 001 |
Primary outcome
The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline.
Time frame: 24 weeks
1 secondary outcome
Proportion of patients with a virologic response; with plasma HIV-1 RNA levels < 50 copies/mL; with plasma HIV-1 RNA levels < 400 copies/mL; Time to loss of virologic response over 144 week treatment period; Change in plasma viral load at all time points
Time frame: 144 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 20 Jun 2014.
- Results publication: PubMed 17621237Molina JM, Cohen C, Katlama C, Grinsztejn B, Timerman A, Pedro Rde J, Vangeneugden T, Miralles D, Meyer SD, Parys W, Lefebvre E; TMC114-C208 Study Group; TMC114-C215 Study Group. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31. doi: 10.1097/QAI.0b013e3181359cfb.
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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
64 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC114 in people with HIV Infection, run by Tibotec Pharmaceuticals, Ireland at 64 sites in 13 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 5 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 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Germany, France, Brazil, Australia and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline. (time frame: 24 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 NCT00081588, 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 20 Jun 2014.