Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals
Double-Blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-Experienced Subjects.
1 other identifier
interventional
165
2 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
Started Apr 2002
Shorter than P25 for phase_2 hiv-infections
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 2, 2002
CompletedFirst Posted
Study publicly available on registry
May 3, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2002
CompletedSeptember 20, 2005
September 1, 2005
May 2, 2002
September 19, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent prior to trial participation.
- HIV-1 infected males or females \>= 18 years of age.
- At least 3 months experience taking NRTIs, NNRTI(s), and PIs.
- 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.
- HIV-1 viral load \>= 1000 copies/mL at screening.
- 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.
- 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.
- Acceptable medical history, as assessed by the investigator, with chest X-ray and ECG within 1 year of study participation.
- 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.
- 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.
You may not qualify if:
- ARV medication naïve.
- 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).
- Any active opportunistic infection within 60 days before study entry.
- Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT \>Grade 1.
- Prior tipranavir use.
- 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.
- Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
- Use of immunomodulatory drugs (e.g. interferon, cyclosporin, hydroxyurea, interleukin-2).
- Active substance abuse.
- Inability to swallow TPV or RTV capsules.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Phoenix Body Positive
Phoenix, Arizona, 85006, United States
Orange County Center for Special Immunology
Fountain Valley, California, 92708, United States
Living Hope Clinical Trials Inc.
Long Beach, California, 90813, United States
AHF Research Center
Los Angeles, California, 90027, United States
University of So. California / LA County USC Medical Center
Los Angeles, California, 90033, United States
ID Care, Inc.
Los Angeles, California, 90046, United States
Tower I.D. Medical Assoc., Inc.
Los Angeles, California, 90048, United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90095, United States
University of California San Francisco Positive Health Program Research
San Francisco, California, 94110, United States
Pacific Horizon Medial Group
San Francisco, California, 94115, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009, United States
(IDC) Research Institute
Altamonte Springs, Florida, 32701, United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308, United States
Jackson Medical Tower
Miami, Florida, 33136, United States
Steinhart Medical Associates
South Miami, Florida, 33133, United States
Hillsborough County Health Dept.
Tampa, Florida, 33602, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Atlanta VA Medical Center, Dept. of ID
Decatur, Georgia, 30033, United States
Mercer University School of Medicine
Macon, Georgia, 31207, United States
CORE Center, Cook County Hospital
Chicago, Illinois, 60612, United States
Rush Presbyterian/St. Luke's Medical Center
Chicago, Illinois, 60612, United States
University of Louisville
Louisville, Kentucky, 40202, United States
HIV Outpatient Program (H.O.P.)
New Orleans, Louisiana, 70112, United States
John's Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Community Research Initiative of New England
Boston, Massachusetts, 02125, United States
CRI Community Research Initiative
Springfield, Massachusetts, 01107, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital, Infectious Diseases Dept.
Detroit, Michigan, 48202, United States
Kansas City Free Health Clinic
Kansas City, Missouri, 64111, United States
Washington University AIDS Clinical Trial Unit
St Louis, Missouri, 63108, United States
Wellness Center
Las Vegas, Nevada, 89102, United States
ID Care, Inc.
Hillsborough, New Jersey, 08844, United States
ID Care, Inc.
Randolph Township, New Jersey, 07869, United States
Southwest CARE Center
Santa Fe, New Mexico, 97505, United States
Albany Medical College
Albany, New York, 12208, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of New York at Stony Brook
Stony Brook, New York, 11794, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center Infectious Diseases Clinic
Durham, North Carolina, 27710, United States
Jemsek Clinic
Huntersville, North Carolina, 28078, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Infect. Disease Institute, Clinical Trials Unit
Oklahoma City, Oklahoma, 73104, United States
Burnside Clinic
Columbia, South Carolina, 29206, United States
Vanderbilt University - AIDS Clinical Trial Unit
Nashville, Tennessee, 37203, United States
Nelson-Tebedo Clinic
Dallas, Texas, 75219, United States
Gathe Clinic
Houston, Texas, 77004, United States
Infectious Disease Physicians Research
Annandale, Virginia, 22003, United States
Clinical Research Puerto Rico
San Juan, 00923, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2002
First Posted
May 3, 2002
Study Start
April 1, 2002
Study Completion
October 1, 2002
Last Updated
September 20, 2005
Record last verified: 2005-09