HIVPhase 2NCT02187107
A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials
A Phase 2 study testing TMC114 and rtv in people with HIV, run by Tibotec Pharmaceuticals, Ireland at 11 sites in 8 countries.
Trial summary
The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- TMC114 and rtv
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 11 sitesin 8 countries
- Study dates
- Jan 2005to Mar 2009
- 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
- Must be diagnosed with HIV
- Previously randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials
- Agreed to take at least 2 antiretroviral agents from baseline onwards
- Could comply with the protocol requirements
- General medical condition, in the investigator's opinion, was not interfering with the assessments and the conduct of the trial
Who cannot join
- A disallowed concomitant therapy
- Current or past history of active alcohol and/or drug use
- Pregnant or breast-feeding females
- Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections)
- Clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis
- Clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication
- Laboratory abnormalities at screening (criteria variable according to the test)
Trial locations and contacts
11 sites in 8 countries.
11 sites in 8 countries
Germany4 sites
Study site
Berlin
Study site
Hamburg
Study site
Hanover
Study site
Munich
About this study
Official title: An Open Label Trial of TMC114/Rtv in HIV-1 Infected Subjects Who Were Randomized in the Trials TMC114-C201, TMC114-C207 or in Sponsor Selected Phase I Trials
The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated.
Read the detailed description
This was a phase II, open label, multicenter trial of an investigational protease inhibitor TMC114 in the presence of ritonavir (rtv) in HIV-1 infected participants who were randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected phase I trials and who might derive benefit from TMC114 therapy, as judged by the investigator.
The trial consisted of a screening period of a maximum of 4 weeks, a 96-week treatment period and a 4-week follow-up period. The maximal trial duration for each participant was104 weeks. During the treatment period, all participants were receiving TMC114 in combination with RTV, orally, as 600/100 mg dose twice daily, in addition to an individually optimized background regimen of antiretroviral (ARV) therapy, selected by the investigator at a baseline of the study.
Sponsor provided a follow-up treatment with TMC114 for all participants who continued to benefit from treatment with TMC114/RTV until it became commercially available for the participant. Participants, who completed the 96 weeks of treatment period with TMC114, had the opportunity to roll over to the extension of this trial, if TMC114 was not locally commercially available.
- Conditions
- HIV
- Being tested
- TMC114, rtv
- Keywords
- HIV, AIDS, TMC114, Ritonavir, Norvir, Darunavir
- 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.
TMC114Drug
300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange
rtvDrug
Also called Norvir
100 mg tablet of Norvir®
| Study group | Role | What they receive |
|---|---|---|
| TMC114 + rtv | Experimental | Every participant recieves 2 tablets of TMC114, 300 mg, combined with one tablet of rtv (ritonavir), 100mg, orally twice daily, every 12 hours Receives: Drug: TMC114; Drug: rtv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination
Measured: Baseline, up to the end of follow-up period (approximatelly 100 weeks)
Secondary outcomes (2)
Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)
The Time to Loss of Virologic Response (TLOVR) algorithm will be used to derive response. Response will be confirmed at 2 consecutive visits and participants who discontinue will be considered nonresponders after discontinuation. Resuppression after confirmed virologic failure will be considered as failure. Virologic Failure will include participants who are rebounders (ie, confirmed viral load >= 50 copies/mL after being a responder) or who were never suppressed (no confirmed viral load <50 copies/mL); non-VF censored: participants who discontinue treatment due to reason other than Virologic Failure will be excluded.
Measured: Week 48, Week 96
Change in CD4 cells absolute count
The immunologic change will be determined by changes in absolute values for CD4 cells.
Measured: Week 48, Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2005
- Primary completionSep 2005
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals Limited, Ireland Clinical Trial, Study director, Tibotec Pharmaceuticals, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187107
- Sponsor's protocol ID
- CR005848
- Other IDs
- TMC114-C208
- Status last verified
- Aug 2014
- First submitted
- 25 Feb 2014
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 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 Subjects Who Were Randomized in the Trials TMC114-C201, TMC114-C207 or in Sponsor Selected Phase I Trials
- ClinicalTrials.gov ID
- NCT02187107
- Acronym / sponsor ID
- CR005848
- Conditions
- HIV
- Keywords
- HIV, AIDS, TMC114, Ritonavir, Norvir, Darunavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Jul 2014 (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 purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated.
Detailed description
This was a phase II, open label, multicenter trial of an investigational protease inhibitor TMC114 in the presence of ritonavir (rtv) in HIV-1 infected participants who were randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected phase I trials and who might derive benefit from TMC114 therapy, as judged by the investigator.
The trial consisted of a screening period of a maximum of 4 weeks, a 96-week treatment period and a 4-week follow-up period. The maximal trial duration for each participant was104 weeks. During the treatment period, all participants were receiving TMC114 in combination with RTV, orally, as 600/100 mg dose twice daily, in addition to an individually optimized background regimen of antiretroviral (ARV) therapy, selected by the investigator at a baseline of the study.
Sponsor provided a follow-up treatment with TMC114 for all participants who continued to benefit from treatment with TMC114/RTV until it became commercially available for the participant. Participants, who completed the 96 weeks of treatment period with TMC114, had the opportunity to roll over to the extension of this trial, if TMC114 was not locally commercially available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMC114 + rtv | Experimental | Drug: TMC114, Drug: rtvEvery participant recieves 2 tablets of TMC114, 300 mg, combined with one tablet of rtv (ritonavir), 100mg, orally twice daily, every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be diagnosed with HIV
- Previously randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials
- Agreed to take at least 2 antiretroviral agents from baseline onwards
- Could comply with the protocol requirements
- General medical condition, in the investigator's opinion, was not interfering with the assessments and the conduct of the trial
Key exclusion criteria (7 listed)
- A disallowed concomitant therapy
- Current or past history of active alcohol and/or drug use
- Pregnant or breast-feeding females
- Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections)
- Clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis
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 |
|---|---|---|
| TMC114300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange | Drug | TMC114 + rtv |
| rtvAlso: Norvir100 mg tablet of Norvir® | Drug | TMC114 + rtv |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination
Time frame: Baseline, up to the end of follow-up period (approximatelly 100 weeks)
2 secondary outcomes
Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)
Time frame: Week 48, Week 96
Change in CD4 cells absolute count
Time frame: Week 48, Week 96
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 25 Aug 2014.
- An Open Label Trial of TMC114/Rtv in HIV-1 Infected Subjects Who Were Randomized in the Trials TMC114-C201, TMC114-C207 or in Sponsor Selected Phase I TrialsLink provided by the sponsor.
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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 Limited, Ireland Clinical Trial study director
Tibotec Pharmaceuticals, Ireland
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC114 and rtv in people with HIV, run by Tibotec Pharmaceuticals, Ireland at 11 sites in 8 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 7 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 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Australia, Austria, Belgium, Denmark and 3 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?
Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination (time frame: Baseline, up to the end of follow-up period (approximatelly 100 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2014.