Conditions: 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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

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.

Arms:
arm 1: TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 2: TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 3: TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 4: TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14

Interventions: intervention 1: TMC310911 75 mg twice daily intervention 2: TMC310911 150 mg twice daily intervention 3: TMC310911 300 mg twice daily intervention 4: TMC310911 300 mg once daily intervention 5: Ritonavir 100 mg twice daily intervention 6: Ritonavir 100 mg once daily
Intervention descriptions: intervention 1: TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14. intervention 2: TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14 intervention 3: TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14 intervention 4: TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14 intervention 5: Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14 intervention 6: Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14

Protocol document: