TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

Recruiting in Palo Alto (17 mi)

+401 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tibotec Pharmaceuticals, Ireland

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals

Research Team

Tibotec Pharmaceuticals Clinical Trial

Principal Investigator

Tibotec Pharmaceutical Limited

Eligibility Criteria

Inclusion Criteria

Patient with documented HIV-1 infection

has limited or no treatment options due to virological failure or intolerance to multiple antiretroviral regimens

is at least 3 class experienced and has previously received 2 different protease inhibitor-based regimens

Treatment Details

Interventions

• Ritonavir (Antiretroviral Therapy)
• TMC114 (Protease Inhibitor)

Who Is Running the Clinical Trial?

Tibotec Pharmaceuticals, Ireland

Lead Sponsor

Trials

77

Recruited

15,700+

Paul Stoffels

Tibotec Pharmaceuticals, Ireland

Chief Executive Officer since 2021

PhD in Microbiology from Miami University

Craig Tendler

Tibotec Pharmaceuticals, Ireland

Chief Medical Officer since 2015

MD from Mount Sinai School of Medicine