Official Title
Early Access of TMC114 in Combination With Low-dose Ritonavir (TMC/r)) and Other Antiretrovirals (ARVs) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to no Treatment Options.
Brief Summary

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

Detailed Description

This is a program to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients, who have failed multiple antiretroviral (ARV) regimens and who are ineligible for participation in any other Tibotec-sponsored HIV trial. Patients need to be at least 3 class experienced (PIs, NRTIs, NtRTIs, NNRTIs or FI), to have previously received 2 different protease inhibitor-based regimens and to not be virologically suppressed on their current regimen. Patients eligible for any other Tibotec sponsored HIV trial but located more than 100 kilometers away from a study site, will be considered eligible for this early access program.

This program will be conducted as an open-label, non-randomized treatment study. Once treatment with TMC114/r in combination with other antiretrovirals (ARVs) has been initiated (baseline visit), patients will follow the recommended visit schedule based on routine clinical care. No other protease inhibitor combinations other than TMC114/r are to be used in this study, except atazanavir (ATV) and indinavir (IDV) may be allowed. Trial medication will be dispensed every 8 weeks. Treatment with TMC114/r will be continued until treatment-limiting toxicity, loss to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 has become commercially available.

Selected safety and tolerability data, including adverse events will be collected throughout the study. A urine pregnancy test will be repeated at baseline for female patients if more than 4 weeks have passed since the test at screening, and urine pregnancy tests will be performed at all other visits. In addition, data on CD4 count and viral load will be collected over the treatment period according to local standard of care practice, in order to ensure that patients continue to benefit from treatment with TMC114/r. A final/withdrawal visit as well as a post-trial treatment follow-up contact (4 weeks after the final/withdrawal visit) will be performed. Patients will take oral doses of 600 mg of TMC114 twice daily in combination with 100 mg of ritonavir twice daily, in combination with other antiretrovirals.

Approved for marketing
HIV Infections

Drug: TMC-114
600/100 mg tablets of TMC114/rtv BID until commercial available to the subject

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

- has a CD4 cell count

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Belgium
Canada
Czech Republic
Denmark
Germany
Greece
Hungary
Luxembourg
Malaysia
Mexico
Netherlands
Puerto Rico
Russian Federation
Slovenia
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United States
Venezuela
Locations

Anniston, Alabama,

Birmingham, Alabama,

Mesa, Arizona,

Phoenix, Arizona,

Tucson, Arizona,

Anaheim, California,

Bakersfield, California,

Baldwin Park, California,

Beverly Hills, California,

Carmichael, California,

Fontana, California,

Fountain Valley, California,

French Camp, California,

Glendale, California,

Harbor City, California,

Hayward, California,

Loma Linda, California,

Long Beach, California,

Los Angeles, California,

Los Angles, California,

Newport Beach, California,

Oakland, California,

Palm Springs, California,

Palo Alto, California,

Panorama City, California,

Paramount, California,

Richmond, California,

Salinas, California,

San Diego, La Jolla, California,

San Diego, California,

San Francisco, California,

San Mateo, California,

San Rafael, California,

Santa Ana, California,

Santa Clara, California,

Santa Clarita, California,

Santa Rosa, California,

Stanford, California,

Sunnyvale, California,

Tarzana, California,

Ukiah, California,

West Hollywood, California,

Woodland Hills, California,

Denver, Colorado,

Glastonbury, Connecticut,

Hartford, Connecticut,

New Haven, Connecticut,

Norwalk, Connecticut,

Norwich, Connecticut,

Stanford, Connecticut,

Vernon Rockville, Connecticut,

Washington, District of Columbia,

Boynton Beach, Florida,

Brandon, Florida,

Fort Lauderdale, Florida,

Fort Laudersale, Florida,

Fort Myers, Florida,

Hollywood, Florida,

Jacksonville, Florida,

Labelle, Florida,

Melbourne, Florida,

Miami Beach, Florida,

Miami, Florida,

N Miami Beach, Florida,

North Palm Beach, Florida,

Orlando, Florida,

Plantation, Florida,

Port St Lucie, Florida,

Safety Harbor, Florida,

Sarasota, Florida,

Tampa, Florida,

Vero Beach, Florida,

West Palm Beach, Florida,

Winter Park, Florida,

Atlanta, Georgia,

Augusta, Georgia,

Austell, Georgia,

Decatur, Georgia,

Jessup, Georgia,

Macon, Georgia,

Marietta, Georgia,

Riverdale, Georgia,

Tucker, Georgia,

Honolulu, Hawaii,

Kahului, Hawaii,

Kapaa, Hawaii,

Boise, Idaho,

Chicago, Illinois,

Decatur, Illinois,

Granite City, Illinois,

Joliet, Illinois,

Rockford, Illinois,

Round Lake Beach, Illinois,

Springfield, Illinois,

Topeka, Kansas,

Henderson, Kentucky,

Paducah, Kentucky,

New Orleans, Louisiana,

Bangor, Maine,

Lewiston, Maine,

Monmouth, Maine,

Portland, Maine,

Baltimore, Maryland,

Bethesda, Maryland,

Elkton, Maryland,

Silver Spring, Maryland,

Boston, Massachusetts,

Cambridge, Massachusetts,

Springfield, Massachusetts,

Berkley, Michigan,

Detroit, Michigan,

Grosse Pointe Woods, Michigan,

Marquette, Michigan,

Minneapolis, Minnesota,

Greenwood, Mississippi,

Columbia, Missouri,

Kansas City, Missouri,

Saint Louis, Missouri,

St. Louis, Missouri,

Las Vegas, Nevada,

Lebanon, New Hampshire,

East Orange, New Jersey,

Galloway, New Jersey,

Hackensack, New Jersey,

Hamilton, New Jersey,

Hoboken, New Jersey,

Jersey City, New Jersey,

Long Branch, New Jersey,

Maplewood, New Jersey,

Neptune, New Jersey,

Newark, New Jersey,

Perth Amboy, New Jersey,

Somers Point, New Jersey,

Voorhees, New Jersey,

West Orange, New Jersey,

Westfield, New Jersey,

Albuquerque, New Mexico,

Albany, New York,

Briarcliff, New York,

Bronxville, New York,

Bronx, New York,

Brooklyn, New York,

Flushing, New York,

Harris, New York,

Manhasset, New York,

Mt. Vernon, New York,

New York, New York,

Rochester, New York,

Syracuse, New York,

Valhalla, New York,

Yonkers, New York,

Asheville, North Carolina,

Chapel Hill, North Carolina,

Greensboro, North Carolina,

Greenville, North Carolina,

Huntersville, North Carolina,

Wilmington, North Carolina,

Winston Salem, North Carolina,

Winston-Salem, North Carolina,

Akron, Ohio,

Cincinnati, Ohio,

Cleveland, Ohio,

Columbus, Ohio,

Dayton, Ohio,

Oklahoma City, Oklahoma,

Portland, Oregon,

Allentown, Pennsylvania,

Easton, Pennsylvania,

Hershey, Pennsylvania,

Philadelphia, Pennsylvania,

Pittsburgh, Pennsylvania,

West Reading, Pennsylvania,

Providence, Rhode Island,

Charleston, South Carolina,

Columbia, South Carolina,

West Columbia, South Carolina,

Hermitage, Tennessee,

Johnson City, Tennessee,

Knoxville, Tennessee,

Memphis, Tennessee,

Nashville, Tennessee,

Austin, Texas,

Bryan, Texas,

Dallas, Texas,

El Paso, Texas,

Fort Worth, Texas,

Galveston, Texas,

Harlingen, Texas,

Houston, Texas,

Lackland, Texas,

Longview, Texas,

San Antonio, Texas,

Annandale, Virginia,

Charlottesville, Virginia,

Fairfax, Virginia,

Hampton, Virginia,

Newport News, Virginia,

Norfolk, Virginia,

Portsmouth, Virginia,

Richmond, Virginia,

Seattle, Washington,

Eau Claire, Wisconsin,

Madison, Wisconsin,

Milwaukee, Wisconsin,

Tibotec Pharmaceuticals Clinical Trial
Study Director
Tibotec Pharmaceutical Limited

Tibotec Pharmaceuticals, Ireland
NCT Number
Keywords
HIV infections
HIV-1
TMC114
Early Access
Highly antiretroviral treatment experienced patients
Anti-retroviral agents
MeSH Terms
HIV Infections
Darunavir