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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
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Phoenix Body Positive
Phoenix, Arizona, United States
Orange County Center for Special Immunology
Fountain Valley, California, United States
Living Hope Clinical Trials Inc.
Long Beach, California, United States
AHF Research Center
Los Angeles, California, United States
University of So. California / LA County USC Medical Center
Los Angeles, California, United States
ID Care, Inc.
Los Angeles, California, United States
Tower I.D. Medical Assoc., Inc.
Los Angeles, California, United States
University of California, Los Angeles Medical Center
Los Angeles, California, United States
University of California San Francisco Positive Health Program Research
San Francisco, California, United States
Pacific Horizon Medial Group
San Francisco, California, United States
...and 41 more locations