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

Completed

• Conditions: HIV Infections

• Registration Number: NCT01297127
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-16
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Adult patients, >/= 18 years of age
• HIV infection
• Treatment-naïve
• Initiation of treatment with Invirase

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Exclusion Criteria

• Contraindications according to Invirase Summary of Product Characteristics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive value of baseline CD4 count and HIV RNA on virological and immunological response at 12, 24 and 48 weeks of treatment	48 weeks

Secondary Outcome Measures

Name	Time	Method
Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment	48 weeks