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

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ClinicalTrials.gov Identifier: NCT01297127
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
HIV Infections

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicentre Noninterventional Observational Study on Predictors of Treatment Response in a Cohort of Treatment naïve HIV-infected Patients Treated With Saquinavir (PROSPECTOR)
Study Start Date : August 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Cohort


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  1. Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment [ Time Frame: 48 weeks ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Treatment-naïve HIV-infected patients initiated on treatment with Invirase
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297127


Locations
Poland
Bialystok, Poland, 15-540
Bydgoszcz, Poland, 85-030
Chorzow, Poland, 41-500
Krakow, Poland, 31-531
Lodz, Poland, 91-347
Warszawa, Poland, 01-201
Wroclaw, Poland, 53-208
Zielona góra, Poland, 65-045
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01297127     History of Changes
Other Study ID Numbers: ML25398
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Saquinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors