Double-Blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-Experienced Subjects.
- NCT00034866
- PHASE2
- INTERVENTIONAL
Last updated: 2005-09-20
Purpose of Trial
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.
This study is for people with
HIV Infections
Interventions being studied
Protease inhibitor tipranavir
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.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
50 Locations
Phoenix
Phoenix Body Positive
Arizona, 85006, United States
Fountain Valley
Orange County Center for Special Immunology
California, 92708, United States
Long Beach
Living Hope Clinical Trials Inc.
California, 90813, United States
Los Angeles
AHF Research Center
California, 90027, United States
Los Angeles
University of So. California / LA County USC Medical Center
California, 90033, United States
Los Angeles
ID Care, Inc.
California, 90046, United States
Los Angeles
Tower I.D. Medical Assoc., Inc.
California, 90048, United States
Los Angeles
University of California, Los Angeles Medical Center
California, 90095, United States
San Francisco
University of California San Francisco Positive Health Program Research
California, 94110, United States
San Francisco
Pacific Horizon Medial Group
California, 94115, United States
Washington
Georgetown University Medical Center
District of Columbia, 20007, United States
Washington
Dupont Circle Physicians Group
District of Columbia, 20009, United States
Altamonte Springs
(IDC) Research Institute
Florida, 32701, United States
Fort Lauderdale
Therafirst Medical Center
Florida, 33308, United States
Miami
Jackson Medical Tower
Florida, 33136, United States
South Miami
Steinhart Medical Associates
Florida, 33133, United States
Tampa
Hillsborough County Health Dept.
Florida, 33602, United States
Vero Beach
Treasure Coast Infectious Disease Consultants
Florida, 32960, United States
Atlanta
AIDS Research Consortium of Atlanta
Georgia, 30308, United States
Decatur
Atlanta VA Medical Center, Dept. of ID
Georgia, 30033, United States
Macon
Mercer University School of Medicine
Georgia, 31207, United States
Chicago
CORE Center, Cook County Hospital
Illinois, 60612, United States
Chicago
Rush Presbyterian/St. Luke's Medical Center
Illinois, 60612, United States
Louisville
University of Louisville
Kentucky, 40202, United States
New Orleans
HIV Outpatient Program (H.O.P.)
Louisiana, 70112, United States
Baltimore
John's Hopkins University School of Medicine
Maryland, 21205, United States
Boston
Community Research Initiative of New England
Massachusetts, 02125, United States
Springfield
CRI Community Research Initiative
Massachusetts, 01107, United States
Ann Arbor
University of Michigan Health System
Michigan, 48109, United States
Detroit
Henry Ford Hospital, Infectious Diseases Dept.
Michigan, 48202, United States
Kansas City
Kansas City Free Health Clinic
Missouri, 64111, United States
St. Louis
Washington University AIDS Clinical Trial Unit
Missouri, 63108, United States
Las Vegas
Wellness Center
Nevada, 89102, United States
Hillsborough
ID Care, Inc.
New Jersey, 08844, United States
Randolph
ID Care, Inc.
New Jersey, 07869, United States
Santa Fe
Southwest CARE Center
New Mexico, 97505, United States
Albany
Albany Medical College
New York, 12208, United States
New York
Mount Sinai School of Medicine
New York, 10029, United States
Stony Brook
University of New York at Stony Brook
New York, 11794, United States
Chapel Hill
University of North Carolina
North Carolina, 27599, United States
Durham
Duke University Medical Center Infectious Diseases Clinic
North Carolina, 27710, United States
Huntersville
Jemsek Clinic
North Carolina, 28078, United States
Winston Salem
Wake Forest University Baptist Medical Center
North Carolina, 27157, United States
Columbus
Ohio State University Medical Center
Ohio, 43210, United States
Oklahoma City
Infect. Disease Institute, Clinical Trials Unit
Oklahoma, 73104, United States
Columbia
Burnside Clinic
South Carolina, 29206, United States
Nashville
Vanderbilt University - AIDS Clinical Trial Unit
Tennessee, 37203, United States
Dallas
Nelson-Tebedo Clinic
Texas, 75219, United States
Houston
Gathe Clinic
Texas, 77004, United States
Annandale
Infectious Disease Physicians Research
Virginia, 22003, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov