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 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
3 other identifiers
interventional
33
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2009
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
March 7, 2013
CompletedJune 12, 2013
June 1, 2013
2 months
February 5, 2009
January 30, 2013
June 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
14 days
Mean Changes From Baseline in CD4+ Cell Count
Baseline (Day 1), Day 8, Day 15
Maximum Plasma Concentration (Cmax) of TMC310911
Day 1 and Day 14
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911
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
Day 1 and Day 14
- +3 more secondary outcomes
Study Arms (4)
TMC310911/rtv 75/100 mg twice daily
EXPERIMENTALTMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/rtv 150/100 mg twice daily
EXPERIMENTALTMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/rtv 300/100 mg twice daily
EXPERIMENTALTMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
TMC310911/rtv 300/100 mg once daily
EXPERIMENTALTMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14
Interventions
TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.
TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14
TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14
TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14
Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14
Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Berlin, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP Head of Discovery & Early Development
- Organization
- Jan-Cil UK
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals, Ireland Clinical Trial
Tibotec Pharmaceuticals, Ireland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 6, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2009
Study Completion
February 1, 2011
Last Updated
June 12, 2013
Results First Posted
March 7, 2013
Record last verified: 2013-06