Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment With Enfuvirtide (Fuzeon) Associated With Two Active Molecules (AMPHORE)
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ClinicalTrials.gov Identifier: NCT00937729 |
Recruitment Status
:
Terminated
(difficult to include patients)
First Posted
: July 13, 2009
Last Update Posted
: February 16, 2012
|
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Condition or disease |
---|
HIV1 Infection HIV Infections |
Study Type : | Observational |
Actual Enrollment : | 4 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment Containing Enfuvirtide (Fuzeon) Associated With Two Active Molecules |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | December 2011 |

Group/Cohort |
---|
enfuvirtide
all patients would received enfuvirtide and and optimised background
|
- viral load compliance [ Time Frame: one year ]
- statistical analysis of MOS HIV [ Time Frame: one year ]

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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: | Non-Probability Sample |
Inclusion Criteria:
- virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status.
Exclusion Criteria:
- hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress

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): NCT00937729
France | |
Borsa-Lebas | |
Rouen, France, 76031 |
Principal Investigator: | BORSA-LEBAS Françoise | CHU Hôpitaux de Rouen |
Responsible Party: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00937729 History of Changes |
Other Study ID Numbers: |
2008/122/HP |
First Posted: | July 13, 2009 Key Record Dates |
Last Update Posted: | February 16, 2012 |
Last Verified: | February 2012 |
Keywords provided by University Hospital, Rouen:
uncompliant patients with virological failure Treatment experienced |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Enfuvirtide HIV Fusion Inhibitors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |