The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs

Recruiting in Palo Alto (17 mi)

+267 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Tibotec Pharmaceuticals, Ireland

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors \[PI\], nucleoside/tide reverse transcriptase inhibitors \[N\[t\]RTIs\] and non-nucleoside reverse transcriptase inhibitors \[NNRTIs\]) or at least 2-class experienced (PIs and N\[t\]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.

Eligibility Criteria

Inclusion Criteria

Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])

Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria

Patient has previously received 2 different PI-based regimens

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