Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent prior to trial participation.
Human immunodeficiency virus 1 (HIV-1) infected males or females \> 18 years of age.
At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
Current PI-based Antiretroviral (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.
Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".
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 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).
You may not be if
ARV medication naïve.
Only one or no available ARV medications as determined by genotypic resistance testing.
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 methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).
Any active opportunistic infection within 60 days before study entry.
Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (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.
Clareo Health | 3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
