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

NCT ID: NCT01297127

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Bialystok, , Poland

Site Status

Bydgoszcz, , Poland

Site Status

Chorzów, , Poland

Site Status

Krakow, , Poland

Site Status

Lodz, , Poland

Site Status

Warsaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Zielona Góra, , Poland

Site Status

Countries

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Poland

Other Identifiers

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ML25398

Identifier Type: -

Identifier Source: org_study_id