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TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options

HIV Infections Clinical Trial

Official title:
Open-label Safety Study of TMC114 in Combination With Low Dose RTV and Other ARVs in Highly Experienced HIV-1 Infected Patients With Limited or no Treatment Options.

Clinical Trial Summary

This is an open-label safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial.

Clinical Trial Description

This is an open-label non-randomized safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial. The safety and tolerability of TMC114 in combination with low dose ritonavir (RTV) and other ARVs in highly ARV-experienced HIV-1 infected patients with limited or no treatment options will be assessed. Treatment will be continued until treatment-limiting toxicity, lost to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 is commercially available to the patient. Total daily dose is 600 mg TMC114 twice daily, each intake in combination with one capsule of 100 mg Ritonavir. Since TMC114 is formulated as 300mg tablets (F014) this means 2X2 tablets per day, taken orally. Treatment will be continued until treatment-limiting toxicity, lost to follow-up, withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 is commercially available to the patient. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00115050
Study type Interventional
Source Tibotec Pharmaceuticals, Ireland
Contact
Status Completed
Phase Phase 3
Start date June 2005
Completion date June 2007
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