NCT00144105TerminatedPhase 2
A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks
Boehringer Ingelheim92 sites in 11 countries562 target enrollmentStarted: February 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 562
- Locations
- 92
- Primary Endpoint
- The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.
Study Overview
Brief Summary
Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent prior to trial participation.
- •HIV-1 infected males or females >= 18 years of age.
- •No previous ARV therapy.
- •Any CD4+ T lymphocyte count < 500 cells / µl.
- •HIV-1 viral load >= 5000 copies/mL at screening.
- •Screening laboratory values that indicate adequate baseline organ function.
- •A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening
- •Exclusion criteria:
- •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
- •Use of investigational medications within 30 days before study entry or during the trial
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.
Secondary Outcomes
- Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.
Investigators
Study Sites (92)
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