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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

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ClinicalTrials.gov Identifier: NCT00838162
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : March 7, 2013
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Description
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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
Human Immunodeficiency Virus Type 1 Drug: TMC310911 75 mg twice daily Drug: TMC310911 150 mg twice daily Drug: TMC310911 300 mg twice daily Drug: TMC310911 300 mg once daily Drug: Ritonavir 100 mg twice daily Drug: Ritonavir 100 mg once daily 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
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Study Type : Interventional  (Clinical Trial)
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 : June 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ritonavir
U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period [ Time Frame: 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.

  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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838162


Locations
Germany
Berlin, Germany
Frankfurt, Germany
Hamburg, Germany
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals, Ireland Clinical Trial Tibotec Pharmaceuticals, Ireland
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00838162     History of Changes
Other Study ID Numbers: CR015952
TMC310911-TIDP21-C201 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
2008-008190-58 ( EudraCT Number )
First Posted: February 6, 2009    Key Record Dates
Results First Posted: March 7, 2013
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Human immunodeficiency virus type 1
HIV-1
HIV-1 treatment-naive
TMC310911
Protease inhibitor
 Ritonavir
Antiviral Activity
HIV Infections
Treatment Naive

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
 Ritonavir
Antiviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors