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T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs Clinical research trials and T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs. T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs clinical trial. Subjects typically recieve the finest healthcare available for their T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche , Trimeris
Synopsis: The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.
Details: Eligible patients remain on their pre-study regimen until baseline. An OB regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening GT/PT antiretroviral resistance testing, and any prior GT/PT antiretroviral resistance (if available). The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. Patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. Patients are randomized to receive 1 of the following 2 treatments for 48 weeks: OB or OB plus T-20. Patients are followed to assess viral load, safety, antiretroviral resistance, T-20 pharmacokinetics, and quality of life. At the end of 48 weeks of treatment patients are allowed to (a) roll over and receive OB plus T-20 (for patients receiving OB regimen alone) or (b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed in this study for a maximum of 100 weeks from their initial baseline visit date.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-infected. - Are at least 16 years old (have consent of parent or guardian if under 18). - Have a viral load (level of HIV in the blood) of 5,000 copies/ml or more. - Have received anti-HIV drugs for at least 6 months and/or have shown resistance to each of the 3 types of anti-HIV drugs as follows: nucleoside reverse transcriptase inhibitors (resistant to 1 or more); nonnucleoside reverse transcriptase inhibitors (resistant to 1 or more); and protease inhibitors (resistant to 2 or more, taken either together or 1 after the other for at least 6 months total).
Total Enrollment: 525
Location and Contact Information:
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
Trevor Slom
Chicago, Illinois, 60611
United States
Toronto Gen Hosp
Toronto, Ontario,
Canada
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, 19106
United States
Peter Tsang
New York City, New York, 10011
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Oregon Health Sciences Univ
Portland, Oregon, 97201
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050
United States
Albany Med College
Albany, New York, 12208
United States
Case Western Reserve Univ / AIDS Clinical Trials Unit
Cleveland, Ohio, 44106
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37212
United States
Centre Hospitalier de la Universite de Montreal (CHUM)
Montreal, Quebec,
Canada
Nicholas Bellos
Dallas, Texas, 75246
United States
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Clinique Medicale L'Actuele
Montreal, Quebec,
Canada
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069
United States
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
United States
San Francisco VA Med Ctr
San Francisco, California, 94121
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, 98104
United States
Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington D.C., District of Columbia, 20009
United States
Regions Hosp
St. Paul, Minnesota, 55101
United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445
United States
MCP Hahnemann Univ
Philadelphia, Pennsylvania, 19102
United States
Univ of Texas Med Branch
Galveston, Texas, 77555
United States
Vancouver Clinic
Vancouver, Washington, 98664
United States
Additional Information:
Study ID Numbers: 295C; T20-301
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008528
Other Hiv Infections Studies:
1. A Study of Lopinavir/Ritonavir in Infants with HIV
2. Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
3. A Study of Patients Who Recently Have Been Infected with HIV
4. Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
5. The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
T-20 with Anti-HIV Combination Therapy for Patients with Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
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