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
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Condition or disease |
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HIV Infections |
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 |

Group/Cohort |
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Cohort |
- 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 ]
- Host- and virus-related factors influencing virological and immunological response at 12, 24 and 48 weeks of treatment [ Time Frame: 48 weeks ]

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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 |
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

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
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |