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.

Phase 2

Terminated

• Conditions: HIV Infections

• Registration Number: NCT00144105
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2006-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 562

Inclusion Criteria

1. Signed informed consent prior to trial participation.
2. HIV-1 infected males or females >= 18 years of age.
3. No previous ARV therapy.
4. Any CD4+ T lymphocyte count < 500 cells / µl.
5. HIV-1 viral load >= 5000 copies/mL at screening.
6. Screening laboratory values that indicate adequate baseline organ function.
7. 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:

1. 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

2. Use of investigational medications within 30 days before study entry or during the trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (62)

Boehringer Ingelheim Investigational Site; 🇬🇧 Edinburgh, United Kingdom

Fundacion Huesped; 🇦🇷 Buenos Aires, Argentina

Hospital de Agudos Teodoro Alvarez; 🇦🇷 Buenos Aires, Argentina

Hospital Posadas; 🇦🇷 Haedo, Argentina

St Vincents Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Princess Margaret Hospital; 🇧🇸 Nassau, Bahamas

Unidade de Pesquisa Clínica (UPC) - AIDS; 🇧🇷 Campinas - Sp, Brazil

Instituto de Crianca / Hospital das Clínicas-FMUSP; 🇧🇷 Mooca / São Paulo, Brazil

Hospital Geral de Nova Iguaçu - Ministério da Saúde; 🇧🇷 Nova Iguaçu - RJ, Brazil

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