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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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
Unnamed facility
Berlin, Germany
Unnamed facility
Frankfurt, Germany
Unnamed facility
Hamburg, Germany
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.
Time frame: Baseline (Day 1), Day 8, Day 15
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.
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
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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
Time frame: 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.
Time frame: Day 14