ESPrES 500 - Evaluation of the safety profile of the new 500 mg film-coated tablet (FCT) formulation of boosted saquinavir (Invirase 500 mg) in HIV-1 infected patients
- Conditions
- HIV-! / AIDSMedDRA version: 9.1Level: LLTClassification code 10000565Term: Acquired immunodeficiency syndrome
- Registration Number
- EUCTR2005-002818-38-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Valutare la sicurezza e la tollerabilita' di saquinavir/ritonavir 1000/100 mg bid usando la formulazione in compresse rivestite con film da 500mg (Invirase® 500 mg) <br>;Secondary Objective: • Valutare la risposta al trattamento tramite la carica virale e la conta dei CD4. • Valutare la sicurezza e la tollerabilita' in differenti tipologie di pazienti (naive ai PI; pazienti che per problemi di tossicita' devono cambiare tipo di inibitori delle proteasi; pazienti in precedenza trattati con PI, ma ancora rispondenti a saquinavir) <br>;Primary end point(s):
- Secondary Outcome Measures
Name Time Method