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

Tibotec Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Human Immunodeficiency Virus Type 1

Treatments: Drug: TMC310911 150 mg twice daily; Drug: Ritonavir 100 mg twice daily; Drug: TMC310911 300 mg once daily; Drug: TMC310911 75 mg twice daily; Drug: Ritonavir 100 mg once daily; Drug: TMC310911 300 mg twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838162

TMC310911-TIDP21-C201 (Other Identifier)

CR015952

2008-008190-58 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

TMC310911/rtv 75/100 mg twice daily

Experimental group

Description:

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

Treatment:

Drug: Ritonavir 100 mg twice daily

Drug: TMC310911 75 mg twice daily

TMC310911/rtv 150/100 mg twice daily

Experimental group

Description:

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

Treatment:

Drug: TMC310911 150 mg twice daily

Drug: Ritonavir 100 mg twice daily

TMC310911/rtv 300/100 mg twice daily

Experimental group

Description:

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

Treatment:

Drug: Ritonavir 100 mg twice daily

Drug: TMC310911 300 mg twice daily

TMC310911/rtv 300/100 mg once daily

Experimental group

Description:

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

Treatment:

Drug: Ritonavir 100 mg once daily

Drug: TMC310911 300 mg once daily