Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01297127
First received: February 15, 2011
Last updated: June 3, 2013
Last verified: June 2013
| Tracking Information | |||||
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| First Received Date ICMJE | February 15, 2011 | ||||
| Last Updated Date | June 3, 2013 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01297127 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection | ||||
| Official Title ICMJE | Prospective Multicentre Noninterventional Observational Study on Predictors of Treatment Response in a Cohort of Treatment naïve HIV-infected Patients Treated With Saquinavir (PROSPECTOR) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Treatment-naïve HIV-infected patients initiated on treatment with Invirase |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Cohort | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 151 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Poland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01297127 | ||||
| Other Study ID Numbers ICMJE | ML25398 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Hoffmann-La Roche | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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