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Home > "D" Clinical Trials Conditions > Dual Boosted- PI PK trial  Dual Boosted- PI PK trial
Dual Boosted- PI PK trial
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: This is an open-label, randomised, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients. The primary objective is to determine the safety and pharmacokinetics of: - TPV/RTV given with an optimized background regimen (OBR) and - TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients meeting the following criteria will be eligible for participation in this study: 1. Signed informed consent prior to trial participation. 2. HIV-1 infected males or females at least 18 years of age. 3. Acceptable laboratory screening values in Trial 1182.12 (RESIST 1) or 1182.48 (RESIST 2), excluding genotype. 4. Genotypic resistance report from screening visit of study RESIST 1 or RESIST 2 indicating at least three mutations at protease codons 33, 82, 84, and 90. 5. At least 3 consecutive months experience taking ARVs from each of the classes of NRTI(s), NNRTI(s), and PIs at some point in treatment history, - with at least 2 PI-based regimens, one of which must be part of the current regimen, and - current PI-based ARV medication regimen for at least 3 months prior to randomization. 6. HIV-1 viral load equal to or greater than 1000 copies/mL at screening. 7. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply: - Total Cholesterol less than or equal to 400 mg/dl or 10.36 mM/L. - Total Triglycerides less than or equal to 750 mg/dl or 8.5 mM/L (less than or equal to DAIDS Grade 2). - ALT less than or equal to 3.0 x ULN and AST less than or equal to 2.5 x ULN (less than or equal to DAIDS Grade 1). - Any Grade GGT is acceptable. - Any Grade CK is acceptable as long as there is no concurrent myopathy. - All other laboratory test values less than or equal to DAIDS Grade 1. 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 during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system. 10. A prior AIDS defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (AIDS related complex is acceptable). EXCLUSION CRITERIA: Patients with any of the following criteria are excluded from participation in the study: 1. ARV medication naïve. 2. Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months. 3. Female patients of child-bearing potential 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 a use barrier method of contraception, or - require ethinyl estradiol administration. 4. Prior tipranavir use. 5. Use of investigational medications within 30 days before study entry or during the trial. (T-20 [enfuvirtide], investigational at the time of writing of this protocol, will be allowed). 6. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin-2). 7. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator. 8. In the opinion of the investigator, likely survival of less than 6 months because of underlying disease.
Total Enrollment:
Location and Contact Information:
Mercer University School of Medicine
Macon, Georgia, 31207
United States
Associates in Research
Ft. Myers, Florida, 33901
United States
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
Dr. Bruce Raushbaum
Washington D.C., District of Columbia, 20037
United States
Community Research Initiative of New England
Springfield, Massachusetts, 01107
United States
(IDC) Research Inititative
Altamonte Springs, Florida, 32701
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
United States
Wohlfeiler, Piperato & King, MD
Miami, Florida, 33139
United States
Early Intervention Program (EIP) Clinic
Camden, New Jersey, 08103
United States
University of New York at Stony Brook
Stony Brook, New York, 11794
United States
Jemsek Clinic
Huntersville, North Carolina, 28078
United States
Albany Medical College
Albany, New York, 12208
United States
Brigham Women's Hospital, Div. of Infectious Diseases
Boston, Massachusetts, 02115
United States
Treasure Coast Infectious Disease Consultant, P.A.
Vero Beach, Florida, 32960
United States
Pollari Medical Group
New York City, New York, 10011
United States
Southwest CARE Center
Santa Fe, New Mexico, 87505
United States
Dr. Joseph Gathe
Houston, Texas, 77004
United States
Community Research Initiative of New England
Boston, Massachusetts, 02125
United States
Orange County Center for Special Immunology
Fountain Valley, California, 92708
United States
Henry Ford Hospital, Infectious Diseases Division
Detroit, Michigan, 48202
United States
Dallas VA Medical Center
Dallas, Texas, 75216
United States
North Broward Hospital District, HIV Clinical Research
Ft. Lauderdale, Florida, 33311
United States
Health Innovations Research
Los Angeles, California, 90046
United States
Wellness Center
Las Vegas, Nevada, 89102
United States
Infectious Disease Physicians Research
Annandale, Virginia, 22003
United States
Infectious Disease Associates
Sarasota, Florida, 34239
United States
Washington VAMC
Washington D.C., District of Columbia, 20422
United States
East Bay AIDS Center
Berkeley, California, 94705
United States
Family Practice Medical Center, Ryan White Clinic
Boise, Idaho, 83704
United States
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, 94118
United States
San Francisco VA Medical Center
San Francisco, California, 94121
United States
Circle Medical, LLC
Norwalk, Connecticut, 06851
United States
Pacific Horizon Medical Group
San Francisco, California, 94115
United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536
United States
Infectious Disease Research Institute
Tampa, Florida, 33614
United States
AHF Research Center
Los Angeles, California, 90027
United States
Veteran's Affairs New Jersey Health Care System
East Orange, New Jersey, 07018
United States
Duke Univ. Med. Ctr. Infect. Diseases Clinic
Durham, North Carolina, 27710
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
AIDS Community Research Initiative of America (ACRIA)
New York City, New York, 10018
United States
Additional Information:
Study ID Numbers: BI 1182.51;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056641
Other Hiv Infections Studies:
1. A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
2. A Study of Nevirapine Used Alone or in Combination with AZT in HIV-1-Infected Children
3. Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS
4. A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
5. A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Dual Boosted- PI PK trial
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