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CompletedNCT00838162Updated Jun 12, 2013Results posted

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 interventional study of TMC310911 75 mg twice daily and TMC310911 150 mg twice daily in Human Immunodeficiency Virus Type 1, sponsored by Tibotec Pharmaceuticals, Ireland. Completed at 3 sites in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-06-12.

Sponsored by Tibotec Pharmaceuticals, Ireland · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
  • Treatment Naive
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 33 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Tibotec Pharmaceuticals, Ireland is the lead sponsor of 75 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • 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 · Drug: Ritonavir 100 mg twice daily

  • 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 · Drug: Ritonavir 100 mg twice daily

  • 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 · Drug: Ritonavir 100 mg twice daily

  • 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 · Drug: Ritonavir 100 mg once daily

Interventions

  • DrugTMC310911 75 mg twice daily

    TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.

  • DrugTMC310911 150 mg twice daily

    TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14

  • DrugTMC310911 300 mg twice daily

    TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14

  • DrugTMC310911 300 mg once daily

    TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14

  • DrugRitonavir 100 mg twice daily

    Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14

  • DrugRitonavir 100 mg once daily

    Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14

06

What researchers measure

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.

    Time frame: Baseline (Day 1), Day 8, Day 15

Secondary outcomes

  1. 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

  2. Mean Changes From Baseline in CD4+ Cell Count

    Time frame: Baseline (Day 1), Day 8, Day 15

  3. Maximum Plasma Concentration (Cmax) of TMC310911

    Time frame: Day 1 and Day 14

  4. Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911

    Time frame: Day 1 and Day 14

  5. 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

  6. 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

  7. Average Steady-state Plasma Concentration (Css,av) of TMC310911

    Time frame: Day 14

  8. 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

07

Results

Posted Mar 7, 2013

Participant flow

This study was conducted in Germany.

Participant flow — Overall Study
MilestoneTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Started9888
Completed9888
Not completed0000

Outcome measures

PrimaryMean 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
Reported as:
Mean · log10 copies/mL
Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)
log10 copies/mLTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Baseline4.72 ± 0.2454.36 ± 0.2594.78 ± 0.1614.71 ± 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
SecondaryNumber 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
Reported as:
Number · Participants
Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period
ParticipantsTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Viral load less than 50 copies/mL0100
Viral load less than 400 copies/mL3410
At least 1 log10 Viral Load Drop9887
SecondaryMean Changes From Baseline in CD4+ Cell Count
Time frame:
Baseline (Day 1), Day 8, Day 15
Reported as:
Mean · x 1000000 cells/L
Mean Changes From Baseline in CD4+ Cell Count
x 1000000 cells/LTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Baseline575.7 ± 56.97464.9 ± 61.32494.0 ± 70.43479.6 ± 39.16
Day 8-21.0 ± 41.2340.3 ± 45.19-14.8 ± 47.5917.9 ± 48.20
Day 15-33.7 ± 27.04-2.8 ± 31.44-2.0 ± 41.2392.5 ± 58.70
SecondaryMaximum Plasma Concentration (Cmax) of TMC310911
Time frame:
Day 1 and Day 14
Reported as:
Mean · ng/mL
Maximum Plasma Concentration (Cmax) of TMC310911
ng/mLTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Day 1487.9 ± 450.3623.0 ± 358.1706.3 ± 553.21924 ± 1048
Day 14589.7 ± 554.11674 ± 652.32256 ± 961.92963 ± 1920
SecondaryTime to Reach the Maximum Plasma Concentration (Tmax) of TMC310911
Time frame:
Day 1 and Day 14
Reported as:
Median · hours
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911
hoursTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Day 15.02 (2.00 to 12.00)5.00 (3.00 to 8.12)5.06 (5.00 to 12.17)5.00 (2.00 to 5.02)
Day 144.98 (1.00 to 8.00)3.00 (1.00 to 5.03)3.87 (0.00 to 5.02)3.02 (1.02 to 5.03)
SecondaryArea 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
Reported as:
Mean · ng.h/mL
Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing
ng.h/mLTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Day 12519 ± 21232735 ± 15722990 ± 224510040 ± 6122
Day 144031 ± 384510680 ± 314716010 ± 822917520 ± 11610
SecondaryPredose Plasma Concentration (C0h) of TMC310911
Time frame:
Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14
Reported as:
Mean · ng/mL
Predose Plasma Concentration (C0h) of TMC310911
ng/mLTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Day 279.95 ± 104.1207.7 ± 122.9231.9 ± 199.945.48 ± 28.94
Day 393.98 ± 92.90448.0 ± 266.1586.3 ± 454.2125.9 ± 69.01
Day 488.94 ± 113.6291.3 ± 170.21035 ± 552.2191.0 ± 175.7
Day 6119.1 ± 182.1443.0 ± 284.7960.5 ± 506.9250.0 ± 236.1
Day 8134.5 ± 179.0665.9 ± 461.11028 ± 724.1239.6 ± 242.6
Day 1078.51 ± 57.88394.4 ± 134.4736.1 ± 435.0251.7 ± 211.0
Day 12104.6 ± 82.91518.6 ± 288.71110 ± 547.5250.2 ± 181.9
Day 14152.5 ± 248.2420.9 ± 244.6924.8 ± 527.9209.9 ± 187.2
SecondaryAverage Steady-state Plasma Concentration (Css,av) of TMC310911
Time frame:
Day 14
Reported as:
Mean · ng/mL
Average Steady-state Plasma Concentration (Css,av) of TMC310911
ng/mLTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Average Steady-state Plasma Concentration (Css,av) of TMC310911336.2 ± 321.3889.6 ± 262.61340 ± 689.6887.3 ± 567.5
SecondaryFluctuation 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
Reported as:
Mean · Percent ng/mL
Fluctuation Index of TMC310911
Percent ng/mLTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
Fluctuation Index of TMC310911181.0 ± 80.00161.3 ± 29.22129.2 ± 52.89331.8 ± 55.47

Adverse events

Collected over Up to 4 weeks after the last dose administration of study medication. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TMC310911/Rtv 75/100 mg Twice Daily—0/9 (0%)5/9 (55.6%)
TMC310911/Rtv 150/100 mg Twice Daily—0/8 (0%)5/8 (62.5%)
TMC310911/Rtv 300/100 mg Twice Daily—0/8 (0%)6/8 (75%)
TMC310911/Rtv 300/100 mg Once a Day—0/8 (0%)3/8 (37.5%)
Most frequent other events
Showing 10 of 28
Most frequent other events
EventTMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a Day
FatigueGeneral disorders3/92/84/80/8
NauseaGastrointestinal disorders1/93/80/80/8
Micturition urgencyRenal and urinary disorders2/90/80/80/8
ConjunctivitisEye disorders0/90/81/80/8
DiarrhoeaGastrointestinal disorders1/91/81/80/8
Dry mouthGastrointestinal disorders0/90/81/80/8
EructationGastrointestinal disorders0/90/80/81/8
Frequent bowel movementsGastrointestinal disorders0/91/81/80/8
ToothacheGastrointestinal disorders0/90/81/80/8
VomitingGastrointestinal disorders0/91/80/80/8

Baseline characteristics

Age Continuous
Age Continuous(years)TMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a DayTotal
Mean29.7 ± 7.2338.1 ± 8.6635.5 ± 6.8737.8 ± 10.1935.1 ± 8.65
Sex: Female, Male
Sex: Female, Male(Participants)TMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a DayTotal
Female10001
Male888832
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TMC310911/Rtv 75/100 mg Twice DailyTMC310911/Rtv 150/100 mg Twice DailyTMC310911/Rtv 300/100 mg Twice DailyTMC310911/Rtv 300/100 mg Once a DayTotal
White888832
Black10001
08

Study locations

3 sites
  • Berlin, Germany
  • Frankfurt, Germany
  • Hamburg, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00838162
Lead sponsor
Tibotec Pharmaceuticals, Ireland
Responsible party
Sponsor
First posted
Feb 6, 2009
Start date
Jun 2009
Primary completion
Aug 2009
Completion
Feb 2011
Results posted
Mar 7, 2013
Last update
Jun 12, 2013

Study contacts

Tibotec Pharmaceuticals, Ireland Clinical Trial
study director · Tibotec Pharmaceuticals, Ireland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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