Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
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| ClinicalTrials.gov Identifier: NCT00615290 |
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Recruitment Status :
Completed
First Posted : February 14, 2008
Results First Posted : February 23, 2010
Last Update Posted : August 8, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
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Brief Summary:
To obtain information on clinical practices for patients treated by Aptivus in real life
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infections | Drug: tipranavir |
| Study Type : | Observational |
| Actual Enrollment : | 42 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy |
| Study Start Date : | June 2007 |
| Actual Primary Completion Date : | May 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Tipranavir
Primary Outcome Measures :
- Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3 [ Time Frame: 6 months after inclusion ]The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3
Secondary Outcome Measures :
- Evaluation of Early Virological Response [ Time Frame: 1 month after inclusion ]Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10
- Viral Load Response at 1 Month [ Time Frame: 1 month after inclusion ]Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL.
- CD4 Count at 1 Month [ Time Frame: 1 month after inclusion ]
- Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL [ Time Frame: 3 months after inclusion ]Number of patients with a viral load < 400 copies/mL after 3 months of treatment
- Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL [ Time Frame: 3 months after inclusion ]Number of patients with a viral load < 50 copies/mL after 3 months of treatment
- Viral Load Response at 3 Months [ Time Frame: 3 months after inclusion ]Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL.
- CD4 Count at 3 Months [ Time Frame: 3 months after inclusion ]
- Patient Self Perception of the New Treatment [ Time Frame: Day 0, month 3 and month 6 ]Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
HIV-infected patients
Criteria
Inclusion Criteria:
- HIV positive patients for whom Aptivus treatment is initiated by their physician
- Aptivus SCP respect
Exclusion Criteria:
None if the inclusion criteria are respected: observational study
Information from the National Library of Medicine
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): NCT00615290
Locations
Show 48 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00615290 |
| Other Study ID Numbers: |
1182.127 |
| First Posted: | February 14, 2008 Key Record Dates |
| Results First Posted: | February 23, 2010 |
| Last Update Posted: | August 8, 2014 |
| Last Verified: | August 2014 |
Additional relevant MeSH terms:
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Tipranavir Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |