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
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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 |
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 |

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
|
- 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.
- 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.
- Mean Changes From Baseline in CD4+ Cell Count [ Time Frame: Baseline (Day 1), Day 8, Day 15 ]
- Maximum Plasma Concentration (Cmax) of TMC310911 [ Time Frame: Day 1 and Day 14 ]
- Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911 [ Time Frame: 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 [ Time Frame: Day 1 and Day 14 ]
- 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 ]
- Average Steady-state Plasma Concentration (Css,av) of TMC310911 [ Time Frame: Day 14 ]
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
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

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
Germany | |
Berlin, Germany | |
Frankfurt, Germany | |
Hamburg, Germany |
Study Director: | Tibotec Pharmaceuticals, Ireland Clinical Trial | Tibotec Pharmaceuticals, Ireland |
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 |