HIV InfectionsPhase 2NCT00513513
TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously
A Phase 2 study testing TMC114 (darunavir) / ritonavir in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
This is an open label study (no placebos are used; all patients will receive the true medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously received anti-HIV drugs), HIV 1 infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- TMC114 (darunavir) / ritonavir
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2007
- 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
- Patients with documented HIV-1 infection
- For the first 11 subjects (Panel A), screening plasma HIV-1 viral load is =10000 copies/mL and <100000 copies/mL
- For the second set of 13 patients (Panel B), plasma HIV-1 viral load is =20000 copies/mL and <500000 copies/mL
- Patients with CD4+ cell count above 100 cells/µl
- Patients have voluntarily signed the ICF
- Patients can comply with the protocol requirements
- Patient's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
Who cannot join
- Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with some exceptions
- Previous or current use of antiretroviral (ARVs/anti-HIV drugs) (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir)
- Having one of protocol listed 1 PI, NRTI, or NNRTI resistance associated mutation at screening
- Patients with primary HIV infection
- Female patients of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
- Any active clinically significant disease (e.g., abnormal heart function, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the patient's safety or outcome in the trial.
About this study
Official title: A Phase II, Open Label Trial in Treatment na�ve, HIV 1 Infected Subjects Who Will Receive TMC114/Rtv as a Monotherapy
This is an open label study (no placebos are used; all patients will receive the true medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously received anti-HIV drugs), HIV 1 infected patients.
Read the detailed description
This is an open label (no placebo), uncontrolled (all patients will receive TMC114 with ritonavir at the same dose, trial to investigate the sustained anti-viral activity of TMC114/rtv monotherapy in 24 treatment naïve, HIV 1 infected patients over a period of 48 weeks.TMC114, 800 mg daily (2 tablets of 400 mg [F021]) will be given together with 1 capsule (100 mg) of ritonavir.Initially 11 subjects (Panel A, screening viral load between 10000 and 100000 copies/mL) will be included and followed for 8 weeks. If after 8 weeks of dosing at least 7 subjects virologically respond (viral load <400 copies/mL), 13 additional patients (Panel B) will be included. If no virologic failure is observed in at least 18 out of 24 patients who complete 8 weeks of dosing, the trial will continue as planned. In case more than 6 patients in Panel A and Panel B develop a virologic failure after 8 weeks of treatment, the trial will be stopped to conclude the treatment is not effective.The 13 additional patients enrolled in Panel B should have a screening viral load between 20000 and 500000 copies/mL. The CD4+ cell count in all 24 patients should be > 100 cells/µL at screening. The patient's medical condition, adverse events (side effects), study medication compliance, and laboratory evaluations for effectiveness and safety will be assessed at regular intervals. At the end of the 48 weeks treatment period patients will be followed for an additional 4 weeks to evaluate any side effects or laboratory abnormalities. Treatment with TMC114/rtv will be extended for all patients who continue to benefit after 48 weeks. 2 oral tablets of TMC114 400 mg will be administered once daily with 1 capsule (100mg) of ritonavir for 48 weeks.
- Conditions
- HIV Infections
- Being tested
- TMC114 (darunavir) / ritonavir
- Keywords
- HIV, AIDS, TMC114, Protease inhibitor, Darunavir, Antiretroviral agents, Treatment Naive
- 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.
TMC114 (darunavir) / ritonavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate sustained anti-viral activity of TMC114/rtv monotherapy in treatment naive, HIV 1 subjects defined by decrease of >1 log viral load (VL) at week 4, VL <400 copies/ml at week 8 and VL< 50 copies/ml at weeks 24 and 48.
Secondary outcomes (1)
The secondary objectives are to evaluate safety and tolerability of TMC114/rtv over 48 weeks, to evaluate immunologic response, to evaluate the possible development of resistance and to monitor potential changes in body shape.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionOct 2007
Why it stopped: Poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513513
- Sponsor's protocol ID
- CR010612
- Status last verified
- Apr 2010
- First submitted
- 6 Aug 2007
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label Trial in Treatment na�ve, HIV 1 Infected Subjects Who Will Receive TMC114/Rtv as a Monotherapy
- ClinicalTrials.gov ID
- NCT00513513
- Acronym / sponsor ID
- CR010612
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, TMC114, Protease inhibitor, Darunavir, Antiretroviral agents, Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 8 Aug 2007 (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.
This is an open label study (no placebos are used; all patients will receive the true medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously received anti-HIV drugs), HIV 1 infected patients.
Detailed description
This is an open label (no placebo), uncontrolled (all patients will receive TMC114 with ritonavir at the same dose, trial to investigate the sustained anti-viral activity of TMC114/rtv monotherapy in 24 treatment naïve, HIV 1 infected patients over a period of 48 weeks.TMC114, 800 mg daily (2 tablets of 400 mg [F021]) will be given together with 1 capsule (100 mg) of ritonavir.Initially 11 subjects (Panel A, screening viral load between 10000 and 100000 copies/mL) will be included and followed for 8 weeks. If after 8 weeks of dosing at least 7 subjects virologically respond (viral load <400 copies/mL), 13 additional patients (Panel B) will be included. If no virologic failure is observed in at least 18 out of 24 patients who complete 8 weeks of dosing, the trial will continue as planned. In case more than 6 patients in Panel A and Panel B develop a virologic failure after 8 weeks of treatment, the trial will be stopped to conclude the treatment is not effective.The 13 additional patients enrolled in Panel B should have a screening viral load between 20000 and 500000 copies/mL. The CD4+ cell count in all 24 patients should be > 100 cells/µL at screening. The patient's medical condition, adverse events (side effects), study medication compliance, and laboratory evaluations for effectiveness and safety will be assessed at regular intervals. At the end of the 48 weeks treatment period patients will be followed for an additional 4 weeks to evaluate any side effects or laboratory abnormalities. Treatment with TMC114/rtv will be extended for all patients who continue to benefit after 48 weeks. 2 oral tablets of TMC114 400 mg will be administered once daily with 1 capsule (100mg) of ritonavir for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with documented HIV-1 infection
- For the first 11 subjects (Panel A), screening plasma HIV-1 viral load is =10000 copies/mL and <100000 copies/mL
- For the second set of 13 patients (Panel B), plasma HIV-1 viral load is =20000 copies/mL and <500000 copies/mL
- Patients with CD4+ cell count above 100 cells/µl
- Patients have voluntarily signed the ICF
Key exclusion criteria (6 listed)
- Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with some exceptions
- Previous or current use of antiretroviral (ARVs/anti-HIV drugs) (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir)
- Having one of protocol listed 1 PI, NRTI, or NNRTI resistance associated mutation at screening
- Patients with primary HIV infection
- Female patients of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
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 |
|---|---|---|
| TMC114 (darunavir) / ritonavir | Drug | – |
Primary outcome
The primary objective is to evaluate sustained anti-viral activity of TMC114/rtv monotherapy in treatment naive, HIV 1 subjects defined by decrease of >1 log viral load (VL) at week 4, VL <400 copies/ml at week 8 and VL< 50 copies/ml at weeks 24 and 48.
1 secondary outcome
The secondary objectives are to evaluate safety and tolerability of TMC114/rtv over 48 weeks, to evaluate immunologic response, to evaluate the possible development of resistance and to monitor potential changes in body shape.
Results and safety
The study was stopped early (reason given: Poor recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2010.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC114 (darunavir) / ritonavir in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland.
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 7 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: stopped early, as of the sponsor's last update on 26 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Poor recruitment.). Results are not available in the source record.
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 objective is to evaluate sustained anti-viral activity of TMC114/rtv monotherapy in treatment naive, HIV 1 subjects defined by decrease of >1 log viral load (VL) at week 4, VL <400 copies/ml at week 8 and VL< 50 copies/ml at weeks 24 and 48.. 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 26 Apr 2010.