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

NCT ID: NCT00838162

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-02-28

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.

Conditions

Human Immunodeficiency Virus Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMC310911/rtv 75/100 mg twice daily

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

Group Type: EXPERIMENTAL

TMC310911 75 mg twice daily

Intervention Type: DRUG

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

Ritonavir 100 mg twice daily

Intervention Type: DRUG

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

TMC310911/rtv 150/100 mg twice daily

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

Group Type: EXPERIMENTAL

TMC310911 150 mg twice daily

Intervention Type: DRUG

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

Ritonavir 100 mg twice daily

Intervention Type: DRUG

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

TMC310911/rtv 300/100 mg twice daily

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

Group Type: EXPERIMENTAL

TMC310911 300 mg twice daily

Intervention Type: DRUG

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

Ritonavir 100 mg twice daily

Intervention Type: DRUG

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

TMC310911/rtv 300/100 mg once daily

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

Group Type: EXPERIMENTAL

TMC310911 300 mg once daily

Intervention Type: DRUG

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

Ritonavir 100 mg once daily

Intervention Type: DRUG

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

Interventions

TMC310911 75 mg twice daily

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

Intervention Type: DRUG

TMC310911 150 mg twice daily

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

Intervention Type: DRUG

TMC310911 300 mg twice daily

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

Intervention Type: DRUG

TMC310911 300 mg once daily

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

Intervention Type: DRUG

Ritonavir 100 mg twice daily

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

Intervention Type: DRUG

Ritonavir 100 mg once daily

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibotec Pharmaceuticals, Ireland Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceuticals, Ireland

Locations

Berlin, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Countries

Germany

Other Identifiers

TMC310911-TIDP21-C201

Identifier Type: OTHER

Identifier Source: secondary_id

2008-008190-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR015952

Identifier Type: -

Identifier Source: org_study_id