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TMC125 in HIV-1 Infected Subjects Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on TMC125 in HIV-1 Infected Subjects conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. TMC125 in HIV-1 Infected Subjects Clinical research trials and TMC125 in HIV-1 Infected Subjects healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including TMC125 in HIV-1 Infected Subjects. TMC125 in HIV-1 Infected Subjects Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a TMC125 in HIV-1 Infected Subjects clinical trial. Participants typically obtain the most effective healthcare available for their TMC125 in HIV-1 Infected Subjects condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > TMC125 in HIV-1 Infected Subjects  TMC125 in HIV-1 Infected Subjects
TMC125 in HIV-1 Infected Subjects
For Condition: HIV Infection
Status: Recruiting
Sponsor(s): Tibotec Pharmaceutical ,
Synopsis: The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks. TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor. There are three treatment groups in the study. One group will be given a dosage of TMC125, 400 mg twice daily. Another will be given 800 mg twice daily. The third group, a control arm, will not receive TMC125. The safety, tolerability and pharmacokinetics (determinations of the concentration of drug in your blood and its evolution over time) of TMC125 will also be evaluated in this study. Patients who have known resistance to NNRTIs and 3 or more protease inhibitor (PI) mutations may be eligible to participate. One-hundred-fifty (150) patients will be enrolled into this study.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Active Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV-1 plasma viral load at screening >1000 copies/ml - Documented genotypic evidence of resistance to currently available NNRTIs - Previous NRTI experience for at least 3 months - 3 primary PI mutations at screening Exclusion Criteria: - Chronic HBV and/or HCV with elevated liver function tests > 3x upper normal limits - Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation) - Previous permanent discontinuation of any NNRTI due to cutaneous events
Total Enrollment: 150
Location and Contact Information:
ID Care *Recruiting*
Hillsborough, New Jersey, 08844
United States
Recruiting Debbie Winters 908-725-2522
North Star Medical Center *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Tyler Thomas 773-296-2400
Tower ID Medical Associates *Not yet recruiting*
Los Angeles, California, 90048
United States
Not yet recruiting Edwin Graham 310-358-2300
Duke University Medical Center *Not yet recruiting*
Durham, North Carolina, 27710
United States
Not yet recruiting Julieta Giner 919-681-4848
University of Wisconsin Medical School *Not yet recruiting*
Madison, Wisconsin, 53226
United States
Not yet recruiting Diane Black 608-265-0316
Pacific Oaks Medical Group *Recruiting*
Beverly Hills, California, 90211
United States
Recruiting Joy Bautista 319-652-8729
IDC Research Initiative *Recruiting*
Altamonte Springs, Florida, 32701
United States
Recruiting Charmane Stiles 407-647-3426
Whitman-Walker Clinic *Not yet recruiting*
Washington D.C., District of Columbia, 20009
United States
Not yet recruiting Christine Geisler 202-745-6150
AIDS Research Consortium of Atlanta *Not yet recruiting*
Atlanta, Georgia, 30308
United States
Not yet recruiting Deede Kauffman 404-876-2317
Rush University Medical Center *Not yet recruiting*
Chicago, Illinois, 60612
United States
Not yet recruiting Jessica Shore 312-942-1964
AIDS Research Alliance *Not yet recruiting*
West Hollywood, California, 90069
United States
Not yet recruiting Corie Castro 310-358-2429
University of Kentucky Medical Centre *Not yet recruiting*
Lexington, Kentucky, 40536
United States
Not yet recruiting Heather Vaughn 859-323-3933
Body Postive *Not yet recruiting*
Phoenix, Arizona, 85006
United States
Not yet recruiting Linda Sirois 602-307-5330
University of Colorado Health Sciences Center *Not yet recruiting*
Denver, Colorado, 80262
United States
Not yet recruiting Graham Ray 303-372-5535
East Bay AIDS Center *Not yet recruiting*
Berkeley, California, 94705
United States
Not yet recruiting Jamie Mandelke 510-204-1291
University of Texas - Houston *Not yet recruiting*
Houston, Texas, 77030
United States
Not yet recruiting Ben Barnett 713-500-6737
USF/Hillsborough City Health Dept *Not yet recruiting*
Tampa, Florida, 33602
United States
Not yet recruiting Stacy Powers 813-307-8015
Albany Medical College *Not yet recruiting*
Albany, New York, 12208
United States
Not yet recruiting Cynthia Morville 518-262-6330
Associates in Medical & Mental Health *Recruiting*
Tulsa, Oklahoma, 74137
United States
Recruiting Frances Haas 918-599-5222
Pacific Horizon Medical Group *Recruiting*
San Francisco, California, 94115
United States
Recruiting Naomi Okinishi 415-292-5477
Polari Medical Group *Recruiting*
New York City, New York, 10011
United States
Recruiting Daniel Dugin 212-929-2629
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Karen Savage 205-975-7925
Orange County Center for Special Immunology *Not yet recruiting*
Fountain Valley, California, 92708
United States
Not yet recruiting Sandra Cassarella 714-751-5800
VA Long Beach Healthcare System *Not yet recruiting*
Long Beach, California, 90822
United States
Not yet recruiting Janice Justis 562-826-5452
University of Miami School Of Medicine *Not yet recruiting*
Miami, Florida, 33136
United States
Not yet recruiting Lynn Healy 305-243-5621
Montrose Clinic *Recruiting*
Houston, Texas, 77098
United States
Recruiting Mark Mall 713-830-3018
UCLA Men's Health Program *Not yet recruiting*
Los Angeles, California, 90024
United States
Not yet recruiting Eunice Williams 310-794-6772
UCLA-Care Center *Not yet recruiting*
Los Angeles, California, 90095
United States
Not yet recruiting Dion Claiborne 310-206-6414
University of California Davis Medical Center *Not yet recruiting*
Sacramento, California, 95814
United States
Not yet recruiting Digna Walker 916-734-8538
Steinhart Medical Associates *Recruiting*
Miami, Florida, 33133
United States
Recruiting Amy Liebermann 305-856-2171
Henry Ford Hospital *Not yet recruiting*
Detroit, Michigan, 48202
United States
Not yet recruiting Diane Smith 313-916-1132
Johns Hopkins University *Not yet recruiting*
Baltimore, Maryland, 21205
United States
Not yet recruiting Michelle Parish 410-614-1338
Beth Israel Medical Center *Not yet recruiting*
New York City, New York, 10003
United States
Not yet recruiting Scott Barnett 212-420-4519
Fanno Creek Clinic *Not yet recruiting*
Portland, Oregon, 97219
United States
Not yet recruiting Lisa Zeigler 503-452-0915
Circle Medical, LLC *Recruiting*
Norwalk, Connecticut, 06903
United States
Recruiting Trish Garton 203-852-9525
Feinberg School of Medicine *Not yet recruiting*
Chicago, Illinois, 60611
United States
Not yet recruiting Patrick Milne 312-695-5045
Clinical Trials Unit *Not yet recruiting*
St. Louis, Missouri, 63108
United States
Not yet recruiting Debra Demarco 314-454-0058
North Bronx Health Network *Not yet recruiting*
Bronx, New York, 10461
United States
Not yet recruiting Jason Leider 718-918-3669
The Research & Education Group *Recruiting*
Portland, Oregon, 97209
United States
Recruiting James Sampson 503-229-8428
Dallas VA Medical Center *Not yet recruiting*
Dallas, Texas, 75216
United States
Not yet recruiting Holly Wise 714-857-1415
Northwest Medical Specialties *Not yet recruiting*
Tacoma, Washington, 98405
United States
Not yet recruiting Catherine Sanders 253-396-5328
Additional Information:
Study ID Numbers: TMC125-C223;
Study Start Date: April 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081978
Other Hiv Infection Studies:
1. Frequency of Parenteral and Non-Parenteral Exposures to Blood Among Healthcare Workers at the Clinical Center, NIH and at Seven Academic Hospitals in Japan
2. Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Persons - A Study in Identical Twin Pairs
3. Study of Tests to Evaluate Effectiveness of Anti-HIV Drugs
4. Immune and Viral Status of HIV-Infected Patients after Stopping Combination Antiretroviral Therapy
5. Combination Drug Treatment of Pediatric HIV Infection
Related Studies:
Other HIV Infection Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
TMC125 in HIV-1 Infected Subjects
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