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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01297127

First received: February 15, 2011

Last updated: September 1, 2016

Last verified: September 2016

History of Changes

Purpose

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
HIV Infections


Study Type:	Observational
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Saquinavir Saquinavir mesylate

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]


Enrollment:	151
Study Start Date:	August 2010
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cohort

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01297127 History of Changes
Other Study ID Numbers:	ML25398
Study First Received:	February 15, 2011
Last Updated:	September 1, 2016
Health Authority:	Poland: Office for Registration of Medicinal Products, Medicinal Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on September 23, 2016

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