Trial information
ESPrES 500 Study: A Study to Evaluate the Safety of a New Tablet Formulation of Boosted Saquinavir in HIV-1 Infected Patients.
Status: Completed
Protocol number: ML19326
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the safety profile of the new 500mg film-coated tablet formulation of boosted saquinavir (Invirase 500mg) in HIV-1 infected patients
Brief summary: This study will evaluate the safety and tolerability of saquinavir/ritonavir 1000/100mg bid when using the Invirase® 500mg film-coated tablet in PI-naive or experienced patients with HIV-1 infection. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 300.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: HIV Infections
Intervention type: Drug
Intervention name: saquinavir[Invirase]
Primary outcome: 1. Percentage of patients with a grade 3 or 4 adverse event.
Key secondary outcomes: 1. Changes in HIV-RNA and CD4;comparison of AEs by patient type; gastrointestinal tolerability; incidence of death.
2. Comparison of AEs by gender, and by patient type; gastrointestinal tolerability; changes in fasting lipid, glucose and transaminases; rashes; changes in HIV-RNA and CD4.
Inclusion criteria:
- adult patients (>=18 years of age) with HIV-1 infection;
- detectable HIV-1 RNA viral load;
- PI naive or experienced.
Exclusion criteria:
- patients receiving Invirase hard gel or soft gel capsules with or without ritonavir;
- patients receiving double boosted PI regimen including saquinavir;
- significant renal dysfunction or hepatic impairment.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/04/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bagno A Ripoli
- Benevento
- Caserta
- Grosseto
- Lecco
- Milano
- Napoli
- Palermo
- Piacenza
- Roma
- Siena
- Taranto
- Torino
- Udine
- Verbania
