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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

Primary Purpose

Human Immunodeficiency Virus Type 1

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

TMC310911 75 mg twice daily

TMC310911 150 mg twice daily

TMC310911 300 mg twice daily

TMC310911 300 mg once daily

Ritonavir 100 mg twice daily

Ritonavir 100 mg once daily

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus Type 1 focused on measuring Human immunodeficiency virus type 1, HIV-1, HIV-1 treatment-naive, TMC310911, Protease inhibitor, Ritonavir, Antiviral Activity, HIV Infections, Treatment Naive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

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 daily

Arm 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 daily on Days 1 to 14

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Mean Changes From Baseline in CD4+ Cell Count

Maximum Plasma Concentration (Cmax) of TMC310911

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

Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing

Predose Plasma Concentration (C0h) of TMC310911

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

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.

Full Information

NCT ID

NCT00838162

First Posted

February 5, 2009

Last Updated

June 3, 2013

Sponsor

Tibotec Pharmaceuticals, Ireland

1. Study Identification

Unique Protocol Identification Number

NCT00838162

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tibotec Pharmaceuticals, Ireland

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TMC310911/rtv 75/100 mg twice daily

Arm Type

Experimental

Arm Description

TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14

Arm Title

TMC310911/rtv 150/100 mg twice daily

Arm Type

Experimental

Arm Description

TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14

Arm Title

TMC310911/rtv 300/100 mg twice daily

Arm Type

Experimental

Arm Description

TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14

Arm Title

TMC310911/rtv 300/100 mg once daily

Arm Type

Experimental

Arm Description

TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14

Intervention Type

Drug

Intervention Name(s)

TMC310911 75 mg twice daily

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TMC310911 150 mg twice daily

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TMC310911 300 mg twice daily

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TMC310911 300 mg once daily

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ritonavir 100 mg twice daily

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ritonavir 100 mg once daily

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)

Description

Time Frame

Baseline (Day 1), Day 8, Day 15

Secondary Outcome Measure Information:

Title

Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period

Description

Time Frame

14 days

Title

Mean Changes From Baseline in CD4+ Cell Count

Time Frame

Baseline (Day 1), Day 8, Day 15

Title

Maximum Plasma Concentration (Cmax) of TMC310911

Time Frame

Day 1 and Day 14

Title

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

Time Frame

Day 1 and Day 14

Title

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

Title

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

Title

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

Time Frame

Day 14

Title

Fluctuation Index of TMC310911

Description

Time Frame

Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tibotec Pharmaceuticals, Ireland Clinical Trial

Organizational Affiliation

Tibotec Pharmaceuticals, Ireland

Official's Role

Study Director

Facility Information:

City

Berlin

Country

Germany

City

Frankfurt

Country

Germany

City

Hamburg

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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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