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Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects Clinical research trials and Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects. Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects  Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects
Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Tibotec Pharmaceutical ,
Synopsis: The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir. Subjects who have previously received all three licensed classes of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate. Four doses of TMC-114/ritonavir will be studied. 300 patients in the United States and Puerto Rico will participate. The duration of the study is 48 weeks.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Major Inclusion Criteria - Male or female, age 18 years or older. - Documented HIV-1 infection. - Stable PI regimen for at least 8 weeks prior to screening. - Plasma viral load at screening above 1000 HIV-1 RNA copies/ml. - Prior use of more than 1 NRTI for at least 3 months. - Prior use of one or more NNRTIs as part of a failing regimen. - At least 1 primary PI mutation as defined by the IAS guidelines. - Treatment with at least two different PIs for a total of at least 3 months. - Suject has given informed consent. Major Exclusion Criteria - Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection. - Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures. - NNRTI as part of therapy at screening. - Patients on a treatment interruption at screening. - Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening. - Hepatitis A, B, or C.
Total Enrollment: 300
Location and Contact Information:
University of North Carolina at Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27516-7215
United States
Recruiting Cheryl Marcus 919-843-8761
University of Cincinnati *Recruiting*
Cincinnati, Ohio, 45267-0405
United States
Recruiting Tammy Powell 513-584-8373
George Washington University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting Suzanne Schuck 202-741-2439
Pacific Horizon Medical Group, Inc. *Recruiting*
San Francisco, California, 94115
United States
Recruiting Amber Orr 415-292-5477
Cornell Clinical Trials Unit *Recruiting*
New York City, New York, 10021
United States
Recruiting Valery Hughes 212-746-4393
Infectious Disease Research Institute, Inc. *Recruiting*
Tampa, Florida, 33614
United States
Recruiting Kalliope Halkias 813-875-4374
North Texas Center for AIDS and Clinical Research *Recruiting*
Dallas, Texas, 75208
United States
Recruiting Joseph Cheatum 214-941-4000
Tower ID Medical Associates *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Shangri-La Jackson 310-358-2300
University of Texas Health Sciences Center at Houston *Not yet recruiting*
Houston, Texas, 77030
United States
Not yet recruiting Raul Nunez 713-500-5483
Clinical Research Center at Tampa *Recruiting*
Tampa, Florida, 33606
United States
Recruiting Anne Howley 813-844-4639
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0435
United States
Recruiting Cheryl Mogridge 409-772-3991
Research Unit of Marcus Conant, MD *Recruiting*
San Francisco, California, 94114
United States
Recruiting Christopher Eden 415-255-0744
University of Pennsylvania Medical Center *Not yet recruiting*
Philadelphia, Pennsylvania, 19104-6073
United States
Not yet recruiting Ruth Brower 215-615-0122
The Rockefeller University Hospital *Not yet recruiting*
New York City, New York, 10021
United States
Not yet recruiting Arlene Hurley 212-448-5020
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Patrick Milne 312-695-5045
South Beach Medical Associates *Recruiting*
Miami, Florida, 33139
United States
Recruiting Doreen Garabedian 305-695-1300
Community Research Initiative of New England - Springfield *Recruiting*
Springfield, Massachusetts, 01107-1635
United States
Recruiting Anne Morris 413-734-2264
Steinhart Medical Associates *Recruiting*
Miami, Florida, 33133
United States
Recruiting Amy Liebmann 305-856-2171
Froedtert and Medical College Infectious Disease Clinic *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Julie Raaum 414-456-7003
University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Beverly Putnam 303-372-5537
Albany Medical College *Recruiting*
Albany, New York, 12208
United States
Recruiting Sandra Preston 518-262-6330
Grady Infectious Disease Program *Not yet recruiting*
Atlanta, Georgia, 30308
United States
Not yet recruiting Ericka Patrick 404-616-6313
The Burnside Clinic *Recruiting*
Columbia, South Carolina, 29206
United States
Recruiting John Windham 803-787-1113
University of California San Francisco *Recruiting*
San Francisco, California, 94110
United States
Recruiting Dean Menegaz 415-476-9296
Johns Hopkins University School of Medicine *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Michelle Parish 410-614-1338
UW AIDS Clinical Trials Unit - University of Washington School of Medicine *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Capital Medical Associates, PC *Recruiting*
Washington D.C., District of Columbia, 20036
United States
Recruiting Alex Seymour 202-822-6311
Therafirst Medical Centers *No longer recruiting*
Ft. Lauderdale, Florida, 33308
United States
No longer recruiting
Treasure Coast Infectious Disease Consultants *Recruiting*
Vero Beach, Florida, 32960
United States
Recruiting Jeff Mieras 772-978-9556
Northstar Medical Center *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Harriett Wittert 773-296-2400
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Theresa Flynn 617-726-3819
Division of Infectious Diseases *Not yet recruiting*
Hershey, Pennsylvania, 17033
United States
Not yet recruiting Mary Hess 717-531-3721
AIDS Healthcare Foundation Research Center *Recruiting*
Los Angeles, California, 90015
United States
Recruiting Chris Rice 323-913-1033
University of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Barbara Rutecki 412-647-8116
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294-2050
United States
Recruiting Karen Savage 205-975-7925
Mercer University School of Medicine *Recruiting*
Macon, Georgia, 31201
United States
Recruiting Sophia James 478-301-5837
Jemsek Clinic *Recruiting*
Huntersville, North Carolina, 28078
United States
Recruiting Paula Hutcherson 704-987-2111
Phoenix Body Positive, Inc. *Recruiting*
Phoenix, Arizona, 85006
United States
Recruiting Linda Sirois 602-307-5330
Pacific Oaks Research *Recruiting*
Beverly Hills, California, 90211
United States
Recruiting Joy Bautista 310-652-8729
Southwest Infectious Disease Associates *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Brenda Gusters 214-828-4702
IDC Research Initiative *Recruiting*
Altamonte Springs, Florida, 32701
United States
Recruiting Joy Edwards 407-647-3960
Case Western Reserve University *Not yet recruiting*
Cleveland, Ohio, 44106
United States
Not yet recruiting Michael Chance 216-844-8051
Obstetrics and Gynecology Department *Not yet recruiting*
San Juan, , 00936-5067
Puerto Rico
Not yet recruiting Georgamaly Estronza 787-753-5913
Living Hope Clinical Foundation *Recruiting*
Long Beach, California, 90813
United States
Recruiting Robert Cordova 562-624-4943
Whitman-Walker Clinic *Recruiting*
Washington D.C., District of Columbia, 20009
United States
Recruiting Christiane Geisler 202-745-6150
HIV Clinical Research *Not yet recruiting*
Ft. Lauderdale, Florida, 33311
United States
Not yet recruiting Howard Yontef 954-467-3006
Columbia University - College of Physicians and Surgeons *Not yet recruiting*
New York City, New York, 10032
United States
Not yet recruiting Mykyelle Crawford 212-305-2665
Fundacion de Investigacion de Diego *Recruiting*
San Juan, , 00909
Puerto Rico
Recruiting Edgardo Aponte 787-722-1248
University of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Kathy Nuffer 619-543-8080
University of Southern California *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Luis Mendez 323-343-8288
Swedish Medical Center *Recruiting*
Seattle, Washington, 98122
United States
Recruiting Heather Algren 206-386-2820
Hampton Roads Medical Specialists *Recruiting*
Hampton, Virginia, 23666
United States
Recruiting Katy Scwarzenberger-Lego 757-838-8677
Atlanta Specialty Research *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Jenny Usherwood 404-459-0002
Community Research Initiative of New England - Boston *Recruiting*
Boston, Massachusetts, 02215-3318
United States
Recruiting Lenore Jackson-Pope 617-778-5454
Additional Information:
Study ID Numbers: TMC114-C202;
Study Start Date: September 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071097
Other Hiv Infections Studies:
1. The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
2. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
3. A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
4. A Multi-Center, Open-Label, Ascending, Multiple Oral dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
5. A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
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Phase 2 study of TMC114 and low dose ritonavir in HIV-1 infected subjects
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