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

TerminadoFase 2ClinicalTrials.gov

ID: NCT00144105Tipo: INTERVENTIONALInicio: 1 de feb de 2004

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

TPV500mg/RTV200mgBID

drug

TPV500mg/RTV100mgBID

drug

LPV400mg/RTV100mgBID

Ubicaciones

Boehringer Ingelheim Investigational Site

BsAs, Argentina

Fundacion Huesped

Buenos Aires, Argentina

Hospital de Agudos Teodoro Alvarez

Buenos Aires, Argentina

Hospital Posadas

Haedo, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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