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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00838162
First received: February 5, 2009
Last updated: June 3, 2013
Last verified: June 2013

February 5, 2009
June 3, 2013
June 2009
August 2009   (final data collection date for primary outcome measure)
Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) [ Time Frame: Baseline (Day 1), Day 8, Day 15 ] [ Designated as safety issue: No ]
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.
Evaluation of the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 2 different twice daily dose regimens of TMC310911 coadministered with ritonavir twice daily.
Complete list of historical versions of study NCT00838162 on ClinicalTrials.gov Archive Site
  • Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Day 1), Day 8, Day 15 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of TMC310911 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average Steady-state Plasma Concentration (Css,av) of TMC310911 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Fluctuation Index of TMC310911 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    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.
Assessment of the viral characteristics, PK and PK/PD relationship, safety and tolerability of the 14-day treatment of 2 different twice daily dose regimens of TMC310911 coadministered with 100 mg ritaonavir twice daily during 14 study visits.
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus Type 1
  • Drug: TMC310911 75 mg twice daily
    TMC310911 75 mg twice daily orally (by mouth) 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: TMC310911 300 mg twice daily
    TMC310911 300 mg twice daily orally (by mouth) 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 twice daily
    Ritonavir 100 mg twice 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
  • Experimental: TMC310911/rtv 75/100 mg twice daily
    TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Drug: TMC310911 300 mg once daily
    • Drug: Ritonavir 100 mg once daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
February 2011
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00838162
CR015952, TMC310911-TIDP21-C201, 2008-008190-58
No
Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceuticals, Ireland
Not Provided
Study Director: Tibotec Pharmaceuticals, Ireland Clinical Trial Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceuticals, Ireland
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP