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
Sponsor
Tibotec Pharmaceuticals, Ireland (Industry)
Overall Status
Completed
CT.gov ID
NCT00838162
Collaborator
(none)
33
3
4
20
11
0.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Study Type:
Interventional
Actual Enrollment
:
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date
:
Jun 1, 2009
Actual Primary Completion Date
:
Aug 1, 2009
Actual Study Completion Date
:
Feb 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TMC310911/rtv 75/100 mg twice daily TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
Drug: TMC310911 75 mg twice daily
TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.
Drug: Ritonavir 100 mg twice daily
Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14
|
| Experimental: TMC310911/rtv 150/100 mg twice daily TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
Drug: TMC310911 150 mg twice daily
TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14
Drug: Ritonavir 100 mg twice daily
Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14
|
| Experimental: TMC310911/rtv 300/100 mg twice daily TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 |
Drug: TMC310911 300 mg twice daily
TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14
Drug: Ritonavir 100 mg twice daily
Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14
|
| Experimental: TMC310911/rtv 300/100 mg once daily TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14 |
Drug: TMC310911 300 mg once daily
TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14
Drug: Ritonavir 100 mg once daily
Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14
|
Outcome Measures
Primary Outcome Measures
- Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) [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.
Secondary Outcome Measures
- Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period [14 days]
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.
- 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 [Day 14]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Berlin | Germany | |||
| 2 | Frankfurt | Germany | |||
| 3 | Hamburg | Germany |
Sponsors and Collaborators
- Tibotec Pharmaceuticals, Ireland
Investigators
- Study Director: Tibotec Pharmaceuticals, Ireland Clinical Trial, Tibotec Pharmaceuticals, Ireland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00838162
Other Study ID Numbers:
- CR015952
- TMC310911-TIDP21-C201
- 2008-008190-58
First Posted:
Feb 6, 2009
Last Update Posted:
Jun 12, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Tibotec Pharmaceuticals, Ireland
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study was conducted in Germany. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Period Title: Overall Study | ||||
| STARTED | 9 | 8 | 8 | 8 |
| COMPLETED | 9 | 8 | 8 | 8 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day | Total |
|---|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 | Total of all reporting groups |
| Overall Participants | 9 | 8 | 8 | 8 | 33 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
29.7
(7.23)
|
38.1
(8.66)
|
35.5
(6.87)
|
37.8
(10.19)
|
35.1
(8.65)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
1
3%
|
| Male |
8
88.9%
|
8
100%
|
8
100%
|
8
100%
|
32
97%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||
| White |
8
88.9%
|
8
100%
|
8
100%
|
8
100%
|
32
97%
|
| Black |
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
1
3%
|
Outcome Measures
| Title | Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to treat (ITT) population- participants who received at least 1 dose of study medication (TMC310911). |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 9 | 8 | 8 | 8 |
| Baseline |
4.72
(0.245)
|
4.36
(0.259)
|
4.78
(0.161)
|
4.71
(0.116)
|
| Day 8 |
-1.30
(0.126)
|
-1.14
(0.147)
|
-1.07
(0.104)
|
-1.06
(0.144)
|
| Day 15 |
-1.53
(0.117)
|
-1.79
(0.192)
|
-1.69
(0.103)
|
-1.55
(0.160)
|
| Title | Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) Population- all randomized participants who received at least 1 dose of study medication (TMC310911) |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 9 | 8 | 8 | 8 |
| Viral load less than 50 copies/mL |
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
| Viral load less than 400 copies/mL |
3
33.3%
|
4
50%
|
1
12.5%
|
0
0%
|
| At least 1 log10 Viral Load Drop |
9
100%
|
8
100%
|
8
100%
|
7
87.5%
|
| Title | Mean Changes From Baseline in CD4+ Cell Count |
|---|---|
| Description | |
| Time Frame | Baseline (Day 1), Day 8, Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) Population - all randomized participants who received at least 1 dose of study medication (TMC310911) |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 9 | 8 | 8 | 8 |
| Baseline |
575.7
(56.97)
|
464.9
(61.32)
|
494.0
(70.43)
|
479.6
(39.16)
|
| Day 8 |
-21.0
(41.23)
|
40.3
(45.19)
|
-14.8
(47.59)
|
17.9
(48.20)
|
| Day 15 |
-33.7
(27.04)
|
-2.8
(31.44)
|
-2.0
(41.23)
|
92.5
(58.70)
|
| Title | Maximum Plasma Concentration (Cmax) of TMC310911 |
|---|---|
| Description | |
| Time Frame | Day 1 and Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 9 | 8 | 8 | 8 |
| Day 1 |
487.9
(450.3)
|
623.0
(358.1)
|
706.3
(553.2)
|
1924
(1048)
|
| Day 14 |
589.7
(554.1)
|
1674
(652.3)
|
2256
(961.9)
|
2963
(1920)
|
| Title | Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911 |
|---|---|
| Description | |
| Time Frame | Day 1 and Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 9 | 8 | 8 | 8 |
| Day 1 |
5.02
|
5.00
|
5.06
|
5.00
|
| Day 14 |
4.98
|
3.00
|
3.87
|
3.02
|
| Title | Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing |
|---|---|
| Description | |
| Time Frame | Day 1 and Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 8 | 8 | 7 | 7 |
| Day 1 |
2519
(2123)
|
2735
(1572)
|
2990
(2245)
|
10040
(6122)
|
| Day 14 |
4031
(3845)
|
10680
(3147)
|
16010
(8229)
|
17520
(11610)
|
| Title | Predose Plasma Concentration (C0h) of TMC310911 |
|---|---|
| Description | |
| Time Frame | Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911). |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 9 | 8 | 8 | 8 |
| Day 2 |
79.95
(104.1)
|
207.7
(122.9)
|
231.9
(199.9)
|
45.48
(28.94)
|
| Day 3 |
93.98
(92.90)
|
448.0
(266.1)
|
586.3
(454.2)
|
125.9
(69.01)
|
| Day 4 |
88.94
(113.6)
|
291.3
(170.2)
|
1035
(552.2)
|
191.0
(175.7)
|
| Day 6 |
119.1
(182.1)
|
443.0
(284.7)
|
960.5
(506.9)
|
250.0
(236.1)
|
| Day 8 |
134.5
(179.0)
|
665.9
(461.1)
|
1028
(724.1)
|
239.6
(242.6)
|
| Day 10 |
78.51
(57.88)
|
394.4
(134.4)
|
736.1
(435.0)
|
251.7
(211.0)
|
| Day 12 |
104.6
(82.91)
|
518.6
(288.7)
|
1110
(547.5)
|
250.2
(181.9)
|
| Day 14 |
152.5
(248.2)
|
420.9
(244.6)
|
924.8
(527.9)
|
209.9
(187.2)
|
| Title | Average Steady-state Plasma Concentration (Css,av) of TMC310911 |
|---|---|
| Description | |
| Time Frame | Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911). |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 8 | 7 | 7 | 8 |
| Mean (Standard Deviation) [ng/mL] |
336.2
(321.3)
|
889.6
(262.6)
|
1340
(689.6)
|
887.3
(567.5)
|
| Title | Fluctuation Index of TMC310911 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911) |
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day |
|---|---|---|---|---|
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 |
| Measure Participants | 8 | 7 | 7 | 8 |
| Mean (Standard Deviation) [Percent ng/mL] |
181.0
(80.00)
|
161.3
(29.22)
|
129.2
(52.89)
|
331.8
(55.47)
|
Adverse Events
| Time Frame | Up to 4 weeks after the last dose administration of study medication | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day | ||||
| Arm/Group Description | TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 | TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14 | ||||
All Cause Mortality |
||||||||
| TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| TMC310911/Rtv 75/100 mg Twice Daily | TMC310911/Rtv 150/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Twice Daily | TMC310911/Rtv 300/100 mg Once a Day | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/9 (55.6%) | 5/8 (62.5%) | 6/8 (75%) | 3/8 (37.5%) | ||||
| Eye disorders | ||||||||
| Conjunctivitis | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain upper | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Abnormal faeces | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Diarrhoea | 1/9 (11.1%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Dry mouth | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Eructation | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Flatulence | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Frequent bowel movements | 0/9 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Nausea | 1/9 (11.1%) | 3/8 (37.5%) | 0/8 (0%) | 0/8 (0%) | ||||
| Toothache | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Vomiting | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | ||||
| General disorders | ||||||||
| Discomfort | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Fatigue | 3/9 (33.3%) | 2/8 (25%) | 4/8 (50%) | 0/8 (0%) | ||||
| Influenza like illness | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Infections and infestations | ||||||||
| Cytomegalovirus hepatitis | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Folliculitis | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | ||||
| Genital herpes | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Nasopharyngitis | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Respiratory tract infection | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Skeletal injury | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | ||||
| Aspartate aminotransferase increased | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Muscle spasms | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | ||||
| Headache | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Renal and urinary disorders | ||||||||
| Micturition urgency | 2/9 (22.2%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Night sweats | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | ||||
| Skin discolouration | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | VP Head of Discovery & Early Development |
|---|---|
| Organization | Jan-Cil UK |
| Phone | 44 1494 553458 |
| ksimmen1@its.jnj.com |
Responsible Party:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00838162
Other Study ID Numbers:
- CR015952
- TMC310911-TIDP21-C201
- 2008-008190-58
First Posted:
Feb 6, 2009
Last Update Posted:
Jun 12, 2013
Last Verified:
Jun 1, 2013