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Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals Clinical research trials and Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals. Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals clinical trial. Participants frequently get the best healthcare available for their Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals  Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals
Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals
For Condition: HIV Infections
Status: Completed
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.
Details: This study will be conducted in HIV+, multiple ARV medication experienced patients. All patients must have received treatment from each of three ARV classes: NRTIs, NNRTIs and PIs, have received at least two PI-based ARV regimens (may include the current regimen) with a viral load greater than or equal to 1000 copies/mL at the time of study entry. The two separate PI-based regimens must each have been taken for at least 3 months. At least one resistance-conferring PI-mutation (from a pre-established panel) must be present. Baseline genotypic screening will be performed and will be used in conjunction with ARV medication history to determine new background therapy for each individual subject to use. Following genotypic screening at baseline, qualifying subjects will be randomized to one of three blinded treatment regimens. Subjects will discontinue their current protease inhibitor and initiate TPV/RTV for 2 weeks of functional monotherapy. Thereafter, the background ARV medications will be optimized and subjects will remain on blinded TPV/RTV plus optimized background therapy for the duration of the trial. Trial duration ranges between 12-32 weeks, depending on when the subject is entered into the trial and the interim analyses for determination of optimized TPV/RTV regimen is completed. On determination of the optimal TPV/RTV dose, subjects may opt to continue open-label treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Signed informed consent prior to trial participation. 2. HIV-1 infected males or females >= 18 years of age. 3. At least 3 months experience taking NRTIs, NNRTI(s), and PIs. 4. Current PI-based ARV medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen. 5. HIV-1 viral load >= 1000 copies/mL at screening. 6. Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M, with not more than one of 82 A/F/T or 84V or 90M. 7. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if severity is no higher than Grade 3 GGT, Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the DAIDS Grading Scale. All laboratory values outside these limits are subject to approval by BI. 8. Acceptable medical history, as assessed by the investigator, with chest X-ray and ECG within 1 year of study participation. 9. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system, such as: grapefruit or Seville oranges or their products; herbal preparations containing St. John’s Wort or milk thistle, and garlic supplements. 10. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment for at least 2 months. Exclusion Criteria: 1. ARV medication naïve. 2. Female subjects who: - have a positive serum pregnancy test at screening or during the study - are breast feeding - are planning to become pregnant - are not willing to use two barrier methods of contraception (e.g. latex condom plus spermicidal jelly/foam). 3. Any active opportunistic infection within 60 days before study entry. 4. Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT >Grade 1. 5. Prior tipranavir use. 6. Use of investigational medications within 30 days before study entry or during the trial. Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable. 7. Use of concomitant drugs which may significantly reduce plasma levels of the study medications. 8. Use of immunomodulatory drugs (e.g. interferon, cyclosporin, hydroxyurea, interleukin-2). 9. Active substance abuse. 10. Inability to swallow TPV or RTV capsules.
Total Enrollment: 165
Location and Contact Information:
Albany Medical College
Albany, New York, 12208
United States
Community Research Initiative of New England
Boston, Massachusetts, 02125
United States
CRI Community Research Initiative
Springfield, Massachusetts, 01107
United States
Infectious Disease Physicians Research
Annandale, Virginia, 22003
United States
Clinical Research Puerto Rico
San Juan, , 00923
Puerto Rico
Therafirst Medical Center
Ft. Lauderdale, Florida, 33308
United States
University of New York at Stony Brook
Stony Brook, New York, 11794
United States
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157
United States
Nelson-Tebedo Clinic
Dallas, Texas, 75219
United States
Burnside Clinic
Columbia, South Carolina, 29206
United States
Pacific Horizon Medial Group
San Francisco, California, 94115
United States
Kansas City Free Health Clinic
Kansas City, Missouri, 64111
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Gathe Clinic
Houston, Texas, 77004
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
United States
HIV Outpatient Program (H.O.P.)
New Orleans, Louisiana, 70112
United States
Mercer University School of Medicine
Macon, Georgia, 31207
United States
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90095
United States
ID Care, Inc.
Los Angeles, California, 90046
United States
Jemsek Clinic
Huntersville, North Carolina, 28078
United States
Infect. Disease Institute, Clinical Trials Unit
Oklahoma City, Oklahoma, 73104
United States
ID Care, Inc.
Hillsborough, New Jersey, 08844
United States
University of So. California / LA County USC Medical Center
Los Angeles, California, 90033
United States
Southwest CARE Center
Santa Fe, New Mexico, 97505
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Rush Presbyterian/St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of California San Francisco Positive Health Program Research
San Francisco, California, 94110
United States
Washington University AIDS Clinical Trial Unit
St. Louis, Missouri, 63108
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Orange County Center for Special Immunology
Fountain Valley, California, 92708
United States
Jackson Medical Tower
Miami, Florida, 33136
United States
Duke University Medical Center Infectious Diseases Clinic
Durham, North Carolina, 27710
United States
ID Care, Inc.
Randolph, New Jersey, 07869
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Hillsborough County Health Dept.
Tampa, Florida, 33602
United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
Vanderbilt University - AIDS Clinical Trial Unit
Nashville, Tennessee, 37203
United States
John's Hopkins University School of Medicine
Baltimore, Maryland, 21205
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Tower I.D. Medical Assoc., Inc.
Los Angeles, California, 90048
United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Wellness Center
Las Vegas, Nevada, 89102
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
CORE Center, Cook County Hospital
Chicago, Illinois, 60612
United States
(IDC) Research Institute
Altamonte Springs, Florida, 32701
United States
AHF Research Center
Los Angeles, California, 90027
United States
Atlanta VA Medical Center, Dept. of ID
Decatur, Georgia, 30033
United States
Living Hope Clinical Trials Inc.
Long Beach, California, 90813
United States
Henry Ford Hospital, Infectious Diseases Dept.
Detroit, Michigan, 48202
United States
Additional Information:
Study ID Numbers: BI 1182.52;
Study Start Date: April 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034866
Other Hiv Infections Studies:
1. Long-Term Effects of HAART in Youth with Stronger Immune Systems Versus Youth with Weaker Immune Systems
2. A Comparison of Two Dose Levels of Indinavir Combined with Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
3. Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
4. A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs
5. A Prospective Double-Blind Study of Retrovir in Early HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Virginia Clinical Trials
Other Annandale Clinical Trials
Dose ranging trial of tipranavir/ritonavir in treatment-experienced HIV infected individuals
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