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Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment Clinical research trials and Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment. Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment clinical trial. Test subjects typically receive the most effective healthcare possible for their Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment  Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment
Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Tibotec Pharmaceutical ,
Synopsis: The purpose of the study is to allow subjects who failed trial treatment in the control group of the TMC114-C202 or TMC114-C213 trials to begin therapy with an investigational protease inhibitor (PI) called TMC114 given with a low dose of ritonavir (RTV). The trial will also evaluate the safety and tolerability of TMC114/RTV. Subjects who participated in the control arm of the TMC114-C202 or TMC114-C213 trial and who meet the specifically defined criteria for virological failure are eligible for screening for TMC114-C215. Furthermore, subjects must have participated in the treatment phase of one of the original trials for at least 12 weeks before becoming eligible for TMC114-C215 screening. A possible 120 subjects many be eligible for the study (the total number of subjects expected in TMC114-C202 and TMC114-C213 control arms) and the study duration is 48 weeks with a possibility of extension. The study is being conducted in the same countries and sites as the TMC114-C202 and TMC114-C213 trials.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Major Inclusion Criteria: - Previous participation in the control group of the TMC114-C202 or TMC114-C213 trials - Significant virologic failure during participation in a control group of the above trials - Subject participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening - Subject agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs) with or without T-20 from baseline onwards - Subject has given informed consent Major Exclusion Criteria: - Current or past history of active alcohol and/or drug use which in the investigator’s opinion would compromise the subject’s safety or compliance to the study protocol procedure - Use of disallowed concomitant therapy - Subject with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels - Any active or unstable medical condition that, in the investigator’s opinion, would compromise the subject’s safety - Subject with laboratory abnormalities at screening as defined by ACTG grading scheme - Subject withdrawing consent from TMC114-C202 or TMC114-C213
Total Enrollment: 120
Location and Contact Information:
University of Pittsburgh *Not yet recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Not yet recruiting Barbara Rutecki 412-647-8116
The University of Texas Southwestern Medical Center at Dallas *Not yet recruiting*
Dallas, Texas, 75235-9173
United States
Not yet recruiting Chip Lohner 214-590-0414
Swedish Medical Center *Not yet recruiting*
Seattle, Washington, 98122
United States
Not yet recruiting Heather Algren 206-386-2820
Pacific Horizon Medical Group, Inc *Recruiting*
San Francisco, California, 94115
United States
Recruiting Amber Orr 415-292-5477
Research Unit of Marcus Conant, MD *Not yet recruiting*
San Francisco, California, 94114
United States
Not yet recruiting Christopher Eden 415-255-0744
George Washington University Medical Center *Not yet recruiting*
Washington D.C., District of Columbia, 20037
United States
Not yet recruiting Suzanne Schuck 202-741-2439
Community Research Initiative of New England *Not yet recruiting*
Springfield, Massachusetts, 01107-1635
United States
Not yet recruiting Anne Morris 413-734-2264
Cornell Clinical Trials Unit *Not yet recruiting*
New York City, New York, 10021
United States
Not yet recruiting Valery Hughes 212-746-4393
University of Cincinnati *Not yet recruiting*
Cincinnati, Ohio, 45267-0405
United States
Not yet recruiting Tammy Powell 513-584-8373
University of Colorado Health Sciences Center *Not yet recruiting*
Denver, Colorado, 80262
United States
Not yet recruiting Beverly Putnam 303-372-5537
Whitman-Walker Clinic *Not yet recruiting*
Washington D.C., District of Columbia, 20009
United States
Not yet recruiting Christiane Geisler 202-745-6150
The Burnside Clinic *Not yet recruiting*
Columbia, South Carolina, 29206
United States
Not yet recruiting John Windham 803-787-1113
University of Texas Health Sciences at Houston *Not yet recruiting*
Houston, Texas, 77030
United States
Not yet recruiting Raul Runez 713-500-5483
Froedtert and Medical College Infectious Disease Clinic *Not yet recruiting*
Milwaukee, Wisconsin, 53226
United States
Not yet recruiting Julie Raaum 414-456-7003
Pacific Oaks Research *Not yet recruiting*
Beverly Hills, California, 90211
United States
Not yet recruiting Joy Bautistia 310-652-8729
Treasure Coast Infectious Disease Consultants *Not yet recruiting*
Vero Beach, Florida, 33606
United States
Not yet recruiting Jeff Mieras 772-978-9556
Massachusetts General Hospital *Not yet recruiting*
Boston, Massachusetts, 02114
United States
Not yet recruiting Theresa Flynn 617-726-3819
Columbia University - College of Physcians and Surgeons *Not yet recruiting*
New York City, New York, 10032
United States
Not yet recruiting Mykyelle Crawford 212-305-2665
North Texas Center for AIDS and Clinical Research *Not yet recruiting*
Dallas, Texas, 75208
United States
Not yet recruiting Joesph Cheatum 214-941-4000
University of Alabama at Birmingham *Not yet recruiting*
Birmingham, Alabama, 35294-2050
United States
Not yet recruiting Karen Savage 205-975-7925
Living Hope Clinical Foundation *Not yet recruiting*
Long Beach, California, 90813
United States
Not yet recruiting Robert Cordorva 562-624-4943
Steinhart Medical Associates *Recruiting*
Miami, Florida, 33133
United States
Recruiting Amy Liebmann 305-856-2171
Infectious Disease Research Institute, Inc. *Not yet recruiting*
Tampa, Florida, 33614
United States
Not yet recruiting Kalliope Halkias 813-875-4374
Grady Infectious Disease Program *Not yet recruiting*
Atlanta, Georgia, 30308
United States
Not yet recruiting Ericka Patrick 404-616-6313
Phoenix Body Positive Inc. *Not yet recruiting*
Phoenix, Arizona, 85006
United States
Not yet recruiting Linda Sirois 602-307-5330
University of California San Francisco *Not yet recruiting*
San Francisco, California, 94110
United States
Not yet recruiting Dean Menegaz 415-476-9296
Capital Medical Associates, PC *Not yet recruiting*
Washington D.C., District of Columbia, 20036
United States
Not yet recruiting Alex Seymour 202-822-6311
University of California, San Diego *Not yet recruiting*
San Diego, California, 92103
United States
Not yet recruiting Kathy Nuffer 619-543-8080
University of Southern California *Not yet recruiting*
Los Angeles, California, 90033
United States
Not yet recruiting Luis Mendez 323-343-8288
Clinical Research Center at Tampa *Not yet recruiting*
Tampa, Florida, 33606
United States
Not yet recruiting Anne Howley 813-844-4639
Northstar Medical Center *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Harriett Wittert 773-296-2400
IDC Research Initiative *Not yet recruiting*
Altamonte Springs, Florida, 32701
United States
Not yet recruiting Joy Edwards 407-647-3960
Atlanta Specialty Research *Not yet recruiting*
Atlanta, Georgia, 30342
United States
Not yet recruiting Jenny Usherwood 404-459-0002
AIDS Healthcare Foundation Research Center *Not yet recruiting*
Los Angeles, California, 90015
United States
Not yet recruiting Chris Rice 323-913-1033
Northwestern University *Not yet recruiting*
Chicago, Illinois, 60611
United States
Not yet recruiting Patrick Milne 312-695-5045
Case Western Reserve University *Not yet recruiting*
Cleveland, Ohio, 44106
United States
Not yet recruiting Michael Chance 216-844-8051
South Beach Medical Associates *Not yet recruiting*
Miami, Florida, 33139
United States
Not yet recruiting Doreen Garabedian 305-695-1300
Community Research Initiative of New England *Recruiting*
Boston, Massachusetts, 02215-3318
United States
Recruiting Lenore Jackson-Pope 617-778-5454
University of Pennsylvania Medical Center *Not yet recruiting*
Philadelphia, Pennsylvania, 19104-6073
United States
Not yet recruiting Ruth Bower 215-615-0122
HIV Clinical Research *Not yet recruiting*
Ft. Lauderdale, Florida, 33311
United States
Not yet recruiting Howard Yontef 954-467-3006
Mercer University School of Medicine *Not yet recruiting*
Macon, Georgia, 31201
United States
Not yet recruiting Sophia James 478-301-5837
Albany Medical College *Not yet recruiting*
Albany, New York, 12208
United States
Not yet recruiting Sandra Preston 518-262-6330
Jemesk Clinic *Not yet recruiting*
Huntersville, North Carolina, 28078
United States
Not yet recruiting Paula Hutcherson 704-987-2111
Division of Infectious Diseases *Not yet recruiting*
Hershey, Pennsylvania, 17033
United States
Not yet recruiting Mary Hess 717-531-3721
Hampton Roads Medical Specialists *Not yet recruiting*
Hampton, Virginia, 23666
United States
Not yet recruiting Katy Scwarzenberger-Lego 757-838-8677
UW AIDS Clinical Trial Unit - University of Washington School of Medicine *Not yet recruiting*
Seattle, Washington, 98104
United States
Not yet recruiting Jeanne Conley 206-731-8877
Tower ID Medical Associates *Not yet recruiting*
Los Angeles, California, 90048
United States
Not yet recruiting Shangri-La Jackson 310-358-2300
University of Minnesota *Not yet recruiting*
Minneapolis, Minnesota, 55404
United States
Not yet recruiting Joann Armstrong 612-863-5241
University of Texas Medical Branch *Not yet recruiting*
Galveston, Texas, 77555-0435
United States
Not yet recruiting Cheryl Mogridge 409-772-3991
Fundacion de Investigacion de Diego *Not yet recruiting*
San Juan, , 00909
Puerto Rico
Not yet recruiting Edgardo Aponte 787-722-1248
Obstetrics and Gynecology Department *Not yet recruiting*
San Juan, , 00936-5067
Puerto Rico
Not yet recruiting Georgamaly Estronza 787-753-5913
Johns Hopkins University School of Medicine *Not yet recruiting*
Baltimore, Maryland, 21287
United States
Not yet recruiting Michelle Parish 410-614-1338
The Rockefeller University Hospital *Not yet recruiting*
New York City, New York, 10021
United States
Not yet recruiting Arlene Hurley 212-448-5020
University of North Carolina at Chapel Hill *Not yet recruiting*
Chapel Hill, North Carolina, 27516-7215
United States
Not yet recruiting Cheryl Marcus 919-843-8761
Southwest Infectious Disease Associates *Not yet recruiting*
Dallas, Texas, 75246
United States
Not yet recruiting Nicholaos Bellos
Additional Information:
Study ID Numbers: TMC114-C215;
Study Start Date: March 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081588
Other Hiv Infections Studies:
1. A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
2. The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
3. Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients
4. The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children with Mild to Moderate Symptoms
5. A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment
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