Status:
COMPLETED
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 patie...
Eligibility Criteria
Inclusion
- 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 one primary protease mutation at the following sites 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M , and
- no more than two protease mutations on codons 33, 82, 84, or 90.
- 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,
- with at least 2 Protease inhibitor-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and
- current Protease inhibitor-based antiretroviral medication regimen for at least 3 months prior to randomisation.
- 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:
- Total cholesterol \<=400 mg/dl or 10,36 mm/L.
- Total triglycerides \<=750 mg/dl or 8,5 mm/L.
- Alanine aminotransferase \<=3x upper limit of normal and aspartate aminotransferase \<=2.5x upper limit of normal.
- Any Grade gamma-glutamyl transpeptidase is acceptable.
- Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
- All other laboratory test values \<= Grade 1(Division of Acquired immune deficiency syndrome, National Institute of Health grading scale).
- 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.
- A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).
Exclusion
- 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.
- 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, or
- are not willing to use a barrier method of contraception, or
- require ethinyl estradiol administration
- 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.
- In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
882 Patients enrolled
Trial Details
Trial ID
NCT00144170
Start Date
February 1 2003
Last Update
July 2 2014
Active Locations (174)
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1
1182.48.5401 Fundación Huésped
Buenos Aires, Argentina
2
1182.48.5402 Fundación Huésped
Buenos Aires, Argentina
3
1182.48.5403 Servicio de Infecciosas
Buenos Aires, Argentina
4
1182.48.5404 Servicio de Infecciosas
Buenos Aires, Argentina