NCT00838162

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	TMC310911 75 mg twice daily	TMC310911 75 mg twice daily orally (by mouth) 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	TMC310911 300 mg twice daily	TMC310911 300 mg twice daily orally (by mouth) 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 twice daily	Ritonavir 100 mg twice 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

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-08-01
• Completion: 2011-02-01
• First posted: 2009-02-06
• Last updated: 2013-06-12
• Results posted: 2013-03-07

Locations

3 sites across 1 country: Germany