Human Immunodeficiency Virus Type 1Phase 2NCT00838162
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
A Phase 2 study testing TMC310911 75 mg twice daily, TMC310911 150 mg twice daily and TMC310911 300 mg twice daily in people with Human Immunodeficiency Virus Type 1, run by Tibotec Pharmaceuticals, Ireland at 3 sites in Germany.
Trial summary
The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Immunodeficiency Virus Type 1
- What is being tested?
- TMC310911 75 mg twice daily, TMC310911 150 mg twice daily and TMC310911 300 mg twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2009to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Documented human immunodeficiency virus type 1 (HIV-1) infection for at least 6 months prior to the screening date
- Participant who has not been treated with a therapeutic HIV vaccine within 1 year prior to enrolment and has never been treated with an antiretroviral (ARV) medication indicated for the treatment of HIV infection or ARVs for treatment of hepatitis B-infection with anti-HIV activity
- Participant agrees not to start antiretroviral therapy (ART) before the baseline visit
- Able to comply with the protocol requirements and have good accessible veins
- HIV-1 plasma viral load at screening visit of above 5,000 HIV-1 Ribonucleic acid copies/mL
- CD4+ cell count above 200 cells/mm3 at screening
Who cannot join
- HIV-2 infected participants and/or participants with any active or chronic hepato-renal disease
- Life expectancy of less than 6 months
- Documented acute (primary) HIV-1 infection
- Pre-existing protease inhibitor (PI) medication resistance
- Any currently active Acquired Immunodeficiency Syndrome (AIDS) - defining illness
- Any active clinically significant disease or findings during screening or medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study
- Any confirmed grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading scale at screening
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Phase IIa, Open-label, Randomized Trial in Treatment-naive HIV-1-infected Subjects to Determine the Antiviral Activity of 14 Days of Monotherapy With 4 Different Dose Regimens of TMC310911 Coadministered With Ritonavir
The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.
Read the detailed description
This is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infected participants (participants who had not been treated with a therapeutic HIV vaccine within 1 year prior to enrollment and who had never been treated with an antiretroviral [ARV] medication indicated for the treatment of HIV-infection or ARVs for treatment of hepatitis B infection with anti-HIV activity prior to screening). In this study approximately 32 participants will be enrolled and randomly assigned to receive 4 different dose regimens co-administered with ritonavir (8 participants in each dosing regimen). The trial will consist of a screening period (maximum 6 weeks), a treatment period with TMC310911 (2 weeks), and a follow-up period (4 weeks). Safety evaluation will include assessment of adverse events, clinical laboratory tests, vital sign measurements, physical examinations and electrocardiograms.
- Conditions
- Human Immunodeficiency Virus Type 1
- Being tested
- TMC310911 75 mg twice daily, TMC310911 150 mg twice daily, TMC310911 300 mg twice daily, TMC310911 300 mg once daily, Ritonavir 100 mg twice daily
- Keywords
- Human immunodeficiency virus type 1, HIV-1, HIV-1 treatment-naive, TMC310911, Protease inhibitor, Ritonavir, Antiviral Activity, HIV Infections, Treatment Naive
- 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.
TMC310911 75 mg twice dailyDrug
TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.
TMC310911 150 mg twice dailyDrug
TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14
TMC310911 300 mg twice dailyDrug
TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14
TMC310911 300 mg once dailyDrug
TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14
Ritonavir 100 mg twice dailyDrug
Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14
Ritonavir 100 mg once dailyDrug
Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14
| Study group | Role | What they receive |
|---|---|---|
| TMC310911/rtv 75/100 mg twice daily | Experimental | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 Receives: Drug: TMC310911 75 mg twice daily; Drug: Ritonavir 100 mg twice daily |
| TMC310911/rtv 150/100 mg twice daily | Experimental | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 Receives: Drug: TMC310911 150 mg twice daily; Drug: Ritonavir 100 mg twice daily |
| TMC310911/rtv 300/100 mg twice daily | Experimental | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 Receives: Drug: TMC310911 300 mg twice daily; Drug: Ritonavir 100 mg twice daily |
| TMC310911/rtv 300/100 mg once daily | Experimental | TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14 Receives: Drug: TMC310911 300 mg once daily; Drug: Ritonavir 100 mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)
The antiviral activity of TMC310911 is measured by the change in viral load from baseline in the 14 days of treatment following initiation of treatment with 4 different dosing regimens of TMC310911 coadministered with ritonavir.
Measured: Baseline (Day 1), Day 8, Day 15
Secondary outcomes (8)
Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period
Virologic response is a viral load test result below a chosen threshold value (less than 50 copies/mL, less than 400 copies/mL, or at least 1 log drop in viral load) at any timepoint during a 14-day treatment of 4 different dose regimens of TMC310911 coadministered with 100 mg ritonavir.
Measured: 14 days
Mean Changes From Baseline in CD4+ Cell Count
Measured: Baseline (Day 1), Day 8, Day 15
Maximum Plasma Concentration (Cmax) of TMC310911
Measured: Day 1 and Day 14
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911
Measured: Day 1 and Day 14
Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing
Measured: Day 1 and Day 14
Predose Plasma Concentration (C0h) of TMC310911
Measured: Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14
Average Steady-state Plasma Concentration (Css,av) of TMC310911
Measured: Day 14
Fluctuation Index of TMC310911
Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus Type 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals, Ireland Clinical Trial, Study director, Tibotec Pharmaceuticals, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838162
- Sponsor's protocol ID
- CR015952
- Other IDs
- TMC310911-TIDP21-C201, 2008-008190-58, 2008
- Status last verified
- Jun 2013
- First submitted
- 5 Feb 2009
- Last updated
- 12 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Open-label, Randomized Trial in Treatment-naive HIV-1-infected Subjects to Determine the Antiviral Activity of 14 Days of Monotherapy With 4 Different Dose Regimens of TMC310911 Coadministered With Ritonavir
- ClinicalTrials.gov ID
- NCT00838162
- Acronym / sponsor ID
- CR015952
- Conditions
- Human Immunodeficiency Virus Type 1
- Keywords
- Human immunodeficiency virus type 1, HIV-1, HIV-1 treatment-naive, TMC310911, Protease inhibitor, Ritonavir, Antiviral Activity, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Posted 7 Mar 2013
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 evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.
Detailed description
This is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infected participants (participants who had not been treated with a therapeutic HIV vaccine within 1 year prior to enrollment and who had never been treated with an antiretroviral [ARV] medication indicated for the treatment of HIV-infection or ARVs for treatment of hepatitis B infection with anti-HIV activity prior to screening). In this study approximately 32 participants will be enrolled and randomly assigned to receive 4 different dose regimens co-administered with ritonavir (8 participants in each dosing regimen). The trial will consist of a screening period (maximum 6 weeks), a treatment period with TMC310911 (2 weeks), and a follow-up period (4 weeks). Safety evaluation will include assessment of adverse events, clinical laboratory tests, vital sign measurements, physical examinations and electrocardiograms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMC310911/rtv 75/100 mg twice daily | Experimental | Drug: TMC310911 75 mg twice daily, Drug: Ritonavir 100 mg twice dailyTMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| TMC310911/rtv 150/100 mg twice daily | Experimental | Drug: TMC310911 150 mg twice daily, Drug: Ritonavir 100 mg twice dailyTMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| TMC310911/rtv 300/100 mg twice daily | Experimental | Drug: TMC310911 300 mg twice daily, Drug: Ritonavir 100 mg twice dailyTMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| TMC310911/rtv 300/100 mg once daily | Experimental | Drug: TMC310911 300 mg once daily, Drug: Ritonavir 100 mg once dailyTMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Documented human immunodeficiency virus type 1 (HIV-1) infection for at least 6 months prior to the screening date
- Participant who has not been treated with a therapeutic HIV vaccine within 1 year prior to enrolment and has never been treated with an antiretroviral (ARV) medication indicated for the treatment of HIV infection or ARVs for treatment of hepatitis B-infection with anti-HIV activity
- Participant agrees not to start antiretroviral therapy (ART) before the baseline visit
- Able to comply with the protocol requirements and have good accessible veins
- HIV-1 plasma viral load at screening visit of above 5,000 HIV-1 Ribonucleic acid copies/mL
Key exclusion criteria (7 listed)
- HIV-2 infected participants and/or participants with any active or chronic hepato-renal disease
- Life expectancy of less than 6 months
- Documented acute (primary) HIV-1 infection
- Pre-existing protease inhibitor (PI) medication resistance
- Any currently active Acquired Immunodeficiency Syndrome (AIDS) - defining illness
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 |
|---|---|---|
| TMC310911 75 mg twice dailyTMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14. | Drug | TMC310911/rtv 75/100 mg twice daily |
| TMC310911 150 mg twice dailyTMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14 | Drug | TMC310911/rtv 150/100 mg twice daily |
| TMC310911 300 mg twice dailyTMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14 | Drug | TMC310911/rtv 300/100 mg twice daily |
| TMC310911 300 mg once dailyTMC310911 300 mg once daily orally (by mouth) on Days 1 to 14 | Drug | TMC310911/rtv 300/100 mg once daily |
| Ritonavir 100 mg twice dailyRitonavir 100 mg twice daily orally (by mouth) on Days 1 to 14 | Drug | TMC310911/rtv 150/100 mg twice daily, TMC310911/rtv 300/100 mg twice daily, TMC310911/rtv 75/100 mg twice daily |
| Ritonavir 100 mg once dailyRitonavir 100 mg once daily orally (by mouth) on Days 1 to 14 | Drug | TMC310911/rtv 300/100 mg once daily |
Primary outcome
Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)
Time frame: Baseline (Day 1), Day 8, Day 15
The antiviral activity of TMC310911 is measured by the change in viral load from baseline in the 14 days of treatment following initiation of treatment with 4 different dosing regimens of TMC310911 coadministered with ritonavir.
8 secondary outcomes
Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period
Time frame: 14 days
Mean Changes From Baseline in CD4+ Cell Count
Time frame: Baseline (Day 1), Day 8, Day 15
Maximum Plasma Concentration (Cmax) of TMC310911
Time frame: Day 1 and Day 14
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911
Time frame: Day 1 and Day 14
Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing
Time frame: Day 1 and Day 14
Predose Plasma Concentration (C0h) of TMC310911
Time frame: Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14
Average Steady-state Plasma Concentration (Css,av) of TMC310911
Time frame: Day 14
Fluctuation Index of TMC310911
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Ireland Clinical Trial study director
Tibotec Pharmaceuticals, Ireland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMC310911 75 mg twice daily, TMC310911 150 mg twice daily and TMC310911 300 mg twice daily in people with Human Immunodeficiency Virus Type 1, run by Tibotec Pharmaceuticals, Ireland at 3 sites in Germany.
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 6 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 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) (time frame: Baseline (Day 1), Day 8, Day 15). 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 12 Jun 2013.