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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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
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: | June 3, 2013 |
| 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 June 13, 2013