HIV-1Phase 4NCT01702090
Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients
A Phase 4 study testing TMC114/ritonavir in people with HIV-1, run by Janssen-Cilag Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have not received previous HIV treatment or have received early treatment without TMC114 regimens. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV-1
- What is being tested?
- TMC114/ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Jun 2012
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with documented HIV-1 infection who are ineligible for participation in any other Sponsor's HIV-1 trial
- Patients have never been treated with antiretroviral (ARV) medications or have prior early treatment-experienced without TMC114 regimens, including they have limited or no treatment options due to virological failure or intolerance to regimens
- Patient's general medical condition, in the investigator's opinion evaluating the patient is eligible for TMC114 containing regimen, does not interfere with the assessments and the completion of the trial
Who cannot join
- Any active clinically significant disease or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase of the trial
- Evidence of active liver disease, acute viral hepatitis, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels; however, patients coinfected with hepatitis B or C will be included if their condition is judged to be clinically stable
- Grade 3 or 4 laboratory abnormalities as defined by Division of AIDS (DAIDS).
- Calculated creatinine clearance (CrCl) less than 50 ml/min
- Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last 30 days after the end of the treatment period
- Any condition (including but not limited to alcohol and/or drug abuse), which in the opinion of the investigator, could compromise the patient's safety or compliance to the study protocol procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Access to TMC114 in Combination With Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or TMC114-naive, Early Treatment Experienced in HIV-1 Infected Patients
The purpose of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have not received previous HIV treatment or have received early treatment without TMC114 regimens.
Read the detailed description
This is a single-treatment-group, open-label (patients and study personnel will know the identity of the treatments given), single-center study. The primary goal of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs, agents that are used to treat viral infections). This study is intended for HIV-1-infected patients who have not received previous HIV treatment (treatment-naive patients) or have received early treatment without TMC114 regimens and who are ineligible to participate in any other sponsored HIV-1 study. This study will monitor and evaluate the safety and efficacy of TMC114/r in combination with ARVs during the course of the study. Treatment with TMC114/r will be continued until virologic failure (the inability to achieve or maintain suppression of viral replication), treatment-limiting toxicity, loss to follow-up, study withdrawal, pregnancy, until discontinuation of TMC114 development or when TMC114 becomes reimbursable for treatment-naive patients or when TMC114 becomes commercially available for treatment-experienced patients.
- Conditions
- HIV-1
- Being tested
- TMC114/ritonavir
- Keywords
- HIV-1, TMC114, Darunavir, PREZISTA, Ritonavir, Antiretrovirals, Early access, Early treatment, Treatment naive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC114/ritonavirDrug
Also called PI
TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs.
| Study group | Role | What they receive |
|---|---|---|
| TMC114/ritonavir | Experimental | Not described Receives: Drug: TMC114/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma HIV-1 RNA level
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
Measured: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
Change in plasma CD4 cell count
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
Measured: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
Secondary outcomes (1)
Number of participants affected by an adverse event
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
Measured: Up to end-of-study visit, an expected average of approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chien-Ching Hung, MD and PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702090
- Sponsor's protocol ID
- CR100712
- Other IDs
- TMC114HIV4073, DRV-C-10-TW01-001
- Status last verified
- May 2016
- First submitted
- 13 Feb 2012
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Access to TMC114 in Combination With Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or TMC114-naive, Early Treatment Experienced in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT01702090
- Acronym / sponsor ID
- CR100712
- Conditions
- HIV-1
- Keywords
- HIV-1, TMC114, Darunavir, PREZISTA, Ritonavir, Antiretrovirals, Early access, Early treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Oct 2012 (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 is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have not received previous HIV treatment or have received early treatment without TMC114 regimens.
Detailed description
This is a single-treatment-group, open-label (patients and study personnel will know the identity of the treatments given), single-center study. The primary goal of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs, agents that are used to treat viral infections). This study is intended for HIV-1-infected patients who have not received previous HIV treatment (treatment-naive patients) or have received early treatment without TMC114 regimens and who are ineligible to participate in any other sponsored HIV-1 study. This study will monitor and evaluate the safety and efficacy of TMC114/r in combination with ARVs during the course of the study. Treatment with TMC114/r will be continued until virologic failure (the inability to achieve or maintain suppression of viral replication), treatment-limiting toxicity, loss to follow-up, study withdrawal, pregnancy, until discontinuation of TMC114 development or when TMC114 becomes reimbursable for treatment-naive patients or when TMC114 becomes commercially available for treatment-experienced patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMC114/ritonavir | Experimental | Drug: TMC114/ritonavir |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with documented HIV-1 infection who are ineligible for participation in any other Sponsor's HIV-1 trial
- Patients have never been treated with antiretroviral (ARV) medications or have prior early treatment-experienced without TMC114 regimens, including they have limited or no treatment options due to virological failure or intolerance to regimens
- Patient's general medical condition, in the investigator's opinion evaluating the patient is eligible for TMC114 containing regimen, does not interfere with the assessments and the completion of the trial
Key exclusion criteria (6 listed)
- Any active clinically significant disease or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase of the trial
- Evidence of active liver disease, acute viral hepatitis, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels; however, patients coinfected with hepatitis B or C will be included if their condition is judged to be clinically stable
- Grade 3 or 4 laboratory abnormalities as defined by Division of AIDS (DAIDS).
- Calculated creatinine clearance (CrCl) less than 50 ml/min
- Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last 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/ritonavirAlso: PITMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs. | Drug | TMC114/ritonavir |
Primary outcome
Change in plasma HIV-1 RNA level
Time frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
Change in plasma CD4 cell count
Time frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
1 secondary outcome
Number of participants affected by an adverse event
Time frame: Up to end-of-study visit, an expected average of approximately 3 months
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 23 May 2016.
- Early access to TMC114 in combination with low-dose ritonavir (tmc114/r) and other Antiretrovirals (AVRs) for treatment-naïve or TMC114-naïve, early treatment-experienced in HIV-1 infected patients.Link 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.
Chien-Ching Hung, MD and PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TMC114/ritonavir in people with HIV-1, run by Janssen-Cilag Ltd. at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in plasma HIV-1 RNA level (time frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months). The study lists 2 primary outcomes in all. 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 23 May 2016.