Clinical Trial Protocol Registry

Trial information

Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection

Status:
Active, not recruiting
Protocol number:
ML25398
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
Prospective multicentre noninterventional observational study on predictors of treatment response in a cohort of treatment naïve HIV-infected patients treated with saquinavir (PROSPECTOR)
Brief summary:
This prospective observational study will evaluate predictors of response to Invirase (saquinavir) treatment in treatment-naïve patients with HIV infection. Data will be collected during 48 weeks of treatment. Target sample size is 151.
Study phase:
IV
Study type:
Observational study
Conditions:
  • HIV Infections
Primary outcome:
  1. Predictive value of baseline CD4 count and HIV RNA on virological and immunological response at 12, 24 and 48 weeks of treatment Time frame: 48 weeks
Key secondary outcomes:
  1. Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment Time frame: 48 weeks
Inclusion criteria:
  • Adult patients, >/= 18 years of age
  • HIV infection
  • Treatment-naïve
  • Initiation of treatment with Invirase
Exclusion criteria:
  • Contraindications according to Invirase Summary of Product Characteristics
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
August, 2010
Trial registration date:
04.02.2011
Date last updated:
04.06.2013
This trial was conducted at the following locations:
Poland
  • BYDGOSZCZ
  • CHORZOW
  • LODZ
  • WARSZAWA
POLAND
  • BIALYSTOK
  • KRAKOW
  • Wroclaw
  • Zielona góra

Link to trial result

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