The purpose of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have not received previous HIV treatment or have received early treatment without TMC114 regimens.
This is a single-treatment-group, open-label (patients and study personnel will know the identity of the treatments given), single-center study. The primary goal of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs, agents that are used to treat viral infections). This study is intended for HIV-1-infected patients who have not received previous HIV treatment (treatment-naive patients) or have received early treatment without TMC114 regimens and who are ineligible to participate in any other sponsored HIV-1 study. This study will monitor and evaluate the safety and efficacy of TMC114/r in combination with ARVs during the course of the study. Treatment with TMC114/r will be continued until virologic failure (the inability to achieve or maintain suppression of viral replication), treatment-limiting toxicity, loss to follow-up, study withdrawal, pregnancy, until discontinuation of TMC114 development or when TMC114 becomes reimbursable for treatment-naive patients or when TMC114 becomes commercially available for treatment-experienced patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs.
Unnamed facility
Taipei, Taiwan
Change in plasma HIV-1 RNA level
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
Time frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
Change in plasma CD4 cell count
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
Time frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months
Number of participants affected by an adverse event
End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.
Time frame: Up to end-of-study visit, an expected average of approximately 3 months
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