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: July 7, 2014
Last verified: July 2014
  Purpose

This prospective observational study will evaluate predictors of response to Inv irase (saquinavir) treatment in treatment-naïve patients with HIV infection. Dat a 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:


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)

  Eligibility

Ages Eligible for Study:   18 Years and older
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

No publications provided

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: July 7, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medicinal Devices and Biocidal Products

Additional relevant MeSH terms:
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
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014