Status:
TERMINATED
A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT00144105
Start Date
February 1 2004
Last Update
November 1 2013
Active Locations (81)
Enter a location and click search to find clinical trials sorted by distance.
1
Boehringer Ingelheim Investigational Site
BsAs, Argentina
2
Fundacion Huesped
Buenos Aires, Argentina
3
Hospital de Agudos Teodoro Alvarez
Buenos Aires, Argentina
4
Hospital Posadas
Haedo, Argentina