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Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients

HIV-1 Clinical Trial

Official title:
Early Access to TMC114 in Combination With Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or TMC114-naive, Early Treatment Experienced in HIV-1 Infected Patients

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01702090
Study type Interventional
Source Janssen-Cilag Ltd.
Contact
Status Completed
Phase Phase 4
Start date February 2012
Completion date June 2012
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