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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: November 3, 2014
Last verified: November 2014

February 15, 2011
November 3, 2014
August 2010
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01297127 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
Prospective Multicentre Noninterventional Observational Study on Predictors of Treatment Response in a Cohort of Treatment naïve HIV-infected Patients Treated With Saquinavir (PROSPECTOR)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Treatment-naïve HIV-infected patients initiated on treatment with Invirase

HIV Infections
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01297127
ML25398
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP