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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002818-38-IT
Enrollment
Unknown
Registered
2008-12-16
Start date
2005-07-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-! / AIDS MedDRA version: 9.1 Level: LLT Classification code 10000565 Term: Acquired immunodeficiency syndrome

Interventions

Trade Name: Invirase Pharmaceutical Form: Coated tablet INN or Proposed INN: Saquinavir Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: NORVIR*4FL

Sponsors

ROCHE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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) ;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) ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026