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.

APPROVED_FOR_MARKETING

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00245739

Run by

Tibotec Pharmaceuticals, Ireland

Last updated by the study team

2014-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• has a CD4 cell count <= 200 cells/mm3
• is not achieving adequate virologic suppression on his/her current regimen and is at risk of clinical or immunologic progression.

You may not qualify if…

• Patient has primary HIV-1 infection (unless documented resistance to all currently approved protease inhibitors participated or is currently participating in a trial with TMC114
• Patient used investigational medication within the last 30 days (except for abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations, and tipranavir)
• Patient suffers from any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or has evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels, or has grade 3 or 4 laboratory abnormalities as defined by National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) grading scheme
• Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Bakersfield, California, United States
• Study site — Baldwin Park, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Carmichael, California, United States
• Study site — Fontana, California, United States
• Study site — Fountain Valley, California, United States
• Study site — French Camp, California, United States
• Study site — Glendale, California, United States
• Study site — Harbor City, California, United States
• Study site — Hayward, California, United States
• Study site — Loma Linda, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angles, California, United States
• Study site — Newport Beach, California, United States
• Study site — Oakland, California, United States
• Study site — Palm Springs, California, United States
• Study site — Palo Alto, California, United States
• Study site — Panorama City, California, United States
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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