Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESI… (NCT00144170) | Clinical Trial Compass
CompletedPhase 3
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
Argentina882 participantsStarted 2003-02
Plain-language summary
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed informed consent prior to trial participation.
✓. Human immunodeficiency virus-1 infected males or females \>=18 years of age.
✓. Screening genotypic resistance report indicating both of the following:
✓. At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,
✓. Human immunodeficiency virus-1 viral load \>=1000 copies/mL at screening.
✓. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
✓. Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.
✓. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
Exclusion criteria
✕. Antiretroviral medication naïve.
✕. Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months.
✕. Alanine aminotransferase \>3x upper limit of normal and aspartate aminotransferase \>2.5x upper limit of normal at either screening visit.
What they're measuring
1
Treatment Response at Week 48
Timeframe: after 48 weeks of treatment
2
Time to Treatment Failure Through 48 Weeks of Treatment
✕. Female patients of child-bearing potential who:
✕. Prior tipranavir use.
✕. Use of investigational medications within 30 days before study entry or during the trial. (T-20 \[enfuvirtide\] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)
✕. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
✕. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.