HIV-InfectionsPhase 1NCT01090648
TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients
A Phase 1 study testing etravirine in people with HIV-Infections, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made. 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?
- etravirine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to May 2010
- Phase
- Phase 1
- 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
- Women must be postmenopausal for at least 2 years, OR be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), OR be not heterosexually active for the duration of the study or have a vasectomized partner (confirmed sterile) OR if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control (as specified below) before entry, and agree to continue to use a highly effective method of contraception throughout the study. Women with tubal ligation are required to use one contraceptive method (Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction)
- All women must have a negative serum or urine pregnancy test at screening. Women of childbearing potential must have a negative urine pregnancy test at other visits
- Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or non-estrogen hormonal based contraceptives) and to not donate sperm during the study
- Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Patient can comply with the protocol requirements
Who cannot join
- Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements
- Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the patient's safety, ability to swallow, or outcome of the trial
- Pregnant or breastfeeding female patient
About this study
Official title: A Study to Survey the Swallowability of Uncoated 200-mg Tablets of Etravirine in HIV-1 Infected Subjects
This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.
Read the detailed description
This trial is designed to elicit the swallowability of two formulations of 200 mg tablets of etravirine (ETR). The trial will allow the assessment of the swallowability of the 200 mg uncoated tablet, the 200 mg film-coated tablet and make comparisons between these tablets and with the current commercially available 100 mg (uncoated) tablets. The trial will be performed in HIV-1 infected patients who are currently taking etravirine (ETR) at a total daily dose of 400 mg (four 100 mg tablets, as whole tablets orally) as part of an antiretroviral regimen with virologic suppression (< 50 copies/mL for at least three months). The trial includes only patients who are already taking etravirine since these patients will have pill taking experience and will also have experience with the commercially available 100 mg tablet formulation. A minimum of 45 patients will be included in the trial to assure a sample representative of the HIV-1 infected population. Patients will be given a single dose of the etravirine (ETR) uncoated 200 mg tablet in the morning, and then complete a questionnaire related to that intake. Within 30 minutes, they will be administered the coated 200 mg formulation, followed by a questionnaire. Assessments of the 200 mg tablets will be made in a single-blinded fashion. As the patient will be administered two 200mg tablets in the morning, he/she does not need to take an evening dose on the day of these assessments. The questionnaire will be used to assess swallowability of the 200 mg formulations and of their current 100 mg tablets, and will also evaluate patient preferences. Patients will be followed up for safety and tolerability for one week due to the short duration the patient will be on study treatment; it will be difficult to distinguish between Adverse Events (AEs) resulting from their current etravirine (ETR) intake (four 100 mg tablets) versus the study intake (two 200 mg tablets). A single dose of an etravirine uncoated 200 mg tablet in the morning, followed by completion of a questionnaire related to that intake. Within 30 minutes, patients will be administered the coated 200 mg formulation, again followed by a questionnaire. Maximum 2 weeks screening, 1 day treatment, 1 week follow up. Total duration of participation is 2 weeks maximum.
- Conditions
- HIV-Infections
- Being tested
- etravirine
- Keywords
- TMC125HIV1083, TMC125, HIV, Etravirine, ETR, Intelence, HIV Infections
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etravirineDrug
One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | etravirine One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet Receives: Drug: etravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet
Measured: Assessment visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 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
- NCT01090648
- Sponsor's protocol ID
- CR017038
- Status last verified
- Dec 2012
- First submitted
- 11 Mar 2010
- Last updated
- 11 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Survey the Swallowability of Uncoated 200-mg Tablets of Etravirine in HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT01090648
- Acronym / sponsor ID
- CR017038
- Conditions
- HIV-Infections
- Keywords
- TMC125HIV1083, TMC125, HIV, Etravirine, ETR, Intelence, HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Mar 2010 (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 trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.
Detailed description
This trial is designed to elicit the swallowability of two formulations of 200 mg tablets of etravirine (ETR). The trial will allow the assessment of the swallowability of the 200 mg uncoated tablet, the 200 mg film-coated tablet and make comparisons between these tablets and with the current commercially available 100 mg (uncoated) tablets. The trial will be performed in HIV-1 infected patients who are currently taking etravirine (ETR) at a total daily dose of 400 mg (four 100 mg tablets, as whole tablets orally) as part of an antiretroviral regimen with virologic suppression (< 50 copies/mL for at least three months). The trial includes only patients who are already taking etravirine since these patients will have pill taking experience and will also have experience with the commercially available 100 mg tablet formulation. A minimum of 45 patients will be included in the trial to assure a sample representative of the HIV-1 infected population. Patients will be given a single dose of the etravirine (ETR) uncoated 200 mg tablet in the morning, and then complete a questionnaire related to that intake. Within 30 minutes, they will be administered the coated 200 mg formulation, followed by a questionnaire. Assessments of the 200 mg tablets will be made in a single-blinded fashion. As the patient will be administered two 200mg tablets in the morning, he/she does not need to take an evening dose on the day of these assessments. The questionnaire will be used to assess swallowability of the 200 mg formulations and of their current 100 mg tablets, and will also evaluate patient preferences. Patients will be followed up for safety and tolerability for one week due to the short duration the patient will be on study treatment; it will be difficult to distinguish between Adverse Events (AEs) resulting from their current etravirine (ETR) intake (four 100 mg tablets) versus the study intake (two 200 mg tablets). A single dose of an etravirine uncoated 200 mg tablet in the morning, followed by completion of a questionnaire related to that intake. Within 30 minutes, patients will be administered the coated 200 mg formulation, again followed by a questionnaire. Maximum 2 weeks screening, 1 day treatment, 1 week follow up. Total duration of participation is 2 weeks maximum.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: etravirineetravirine One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women must be postmenopausal for at least 2 years, OR be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), OR be not heterosexually active for the duration of the study or have a vasectomized partner (confirmed sterile) OR if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control (as specified below) before entry, and agree to continue to use a highly effective method of contraception throughout the study. Women with tubal ligation are required to use one contraceptive method (Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction)
- All women must have a negative serum or urine pregnancy test at screening. Women of childbearing potential must have a negative urine pregnancy test at other visits
- Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or non-estrogen hormonal based contraceptives) and to not donate sperm during the study
- Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Patient can comply with the protocol requirements
Key exclusion criteria (3 listed)
- Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements
- Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the patient's safety, ability to swallow, or outcome of the trial
- Pregnant or breastfeeding female patient
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 |
|---|---|---|
| etravirineOne etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet | Drug | 001 |
Primary outcome
Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet
Time frame: Assessment visit (Day 1)
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 11 Dec 2012.
- A study to survey the swallowability of non-coated 200-mg tablets of etravirine in HIV-1 infected subjectsLink provided by the sponsor.
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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 1 study testing etravirine 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 5 inclusion and 3 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 11 Dec 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Questionnaire using a 7-point scale to determine the acceptability of swallowing an uncoated 200 mg etravirine (ETR) tablet (time frame: Assessment visit (Day 1)). 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 11 Dec 2012.