Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01297127
First received: February 15, 2011
Last updated: February 5, 2015
Last verified: February 2015
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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:
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 |
| 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
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: | February 5, 2015 |
| Health Authority: | Poland: Office for Registration of Medicinal Products, Medicinal Devices and Biocidal Products |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections |
RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015