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| ID | Type | Description | Link |
|---|---|---|---|
| TMC310911-TIDP21-C201 | Other Identifier | Tibotec Pharmaceuticals, Ireland | |
| 2008-008190-58 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC310911/rtv 75/100 mg twice daily | Experimental | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
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| TMC310911/rtv 150/100 mg twice daily | Experimental | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
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| TMC310911/rtv 300/100 mg twice daily | Experimental | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
|
| TMC310911/rtv 300/100 mg once daily | Experimental | TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC310911 75 mg twice daily | Drug | TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibotec Pharmaceuticals, Ireland Clinical Trial | Tibotec Pharmaceuticals, Ireland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
In total, 41 participants were screened of whom 33 participants were randomized and treated with TMC310911. All treated participants completed the study; there were no dropouts or discontinuations during the study.
This study was conducted in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| FG001 | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| TMC310911 150 mg twice daily | Drug | TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14 |
|
| TMC310911 300 mg twice daily | Drug | TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14 |
|
| TMC310911 300 mg once daily | Drug | TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14 |
|
| Ritonavir 100 mg twice daily | Drug | Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14 |
|
| Ritonavir 100 mg once daily | Drug | Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14 |
|
| 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 |
| Predose Plasma Concentration (C0h) of TMC310911 | 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 | 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. | Day 14 |
| Frankfurt |
| Germany |
| Hamburg | Germany |
| FG002 | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| FG003 | TMC310911/Rtv 300/100 mg Once a Day | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| BG001 | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| BG002 | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
| BG003 | TMC310911/Rtv 300/100 mg Once a Day | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to treat (ITT) population- participants who received at least 1 dose of study medication (TMC310911). | Posted | Mean | Standard Error | log10 copies/mL | Baseline (Day 1), Day 8, Day 15 |
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| Secondary | 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. | Intent-to-treat (ITT) Population- all randomized participants who received at least 1 dose of study medication (TMC310911) | Posted | Number | Participants | 14 days |
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| Secondary | Mean Changes From Baseline in CD4+ Cell Count | Intent-to-treat (ITT) Population - all randomized participants who received at least 1 dose of study medication (TMC310911) | Posted | Mean | Standard Error | x 1000000 cells/L | Baseline (Day 1), Day 8, Day 15 |
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| Secondary | Maximum Plasma Concentration (Cmax) of TMC310911 | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) | Posted | Mean | Standard Deviation | ng/mL | Day 1 and Day 14 |
|
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| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911 | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) | Posted | Median | Full Range | hours | Day 1 and Day 14 |
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| Secondary | Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) | Posted | Mean | Standard Deviation | ng.h/mL | Day 1 and Day 14 |
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| Secondary | Predose Plasma Concentration (C0h) of TMC310911 | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911). | Posted | Mean | Standard Deviation | ng/mL | Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14 |
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| Secondary | Average Steady-state Plasma Concentration (Css,av) of TMC310911 | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911). | Posted | Mean | Standard Deviation | ng/mL | Day 14 |
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| Secondary | 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. | Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) | Posted | Mean | Standard Deviation | Percent ng/mL | Day 14 |
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Up to 4 weeks after the last dose administration of study medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | 0 | 9 | 5 | 9 | ||
| EG001 | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | 0 | 8 | 5 | 8 | ||
| EG002 | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | 0 | 8 | 6 | 8 | ||
| EG003 | TMC310911/Rtv 300/100 mg Once a Day | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 | 0 | 8 | 3 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abnormal faeces | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Discomfort | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Cytomegalovirus hepatitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Genital herpes | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Head of Discovery & Early Development | Jan-Cil UK | 44 1494 553458 | ksimmen1@its.jnj.com |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000711727 | TMC-310911 |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Black |
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| Day 8 |
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| Day 15 |
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TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
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