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)
This study has been terminated.
(difficult to include patients)
Information provided by (Responsible Party):
University Hospital, Rouen
First received: July 10, 2009
Last updated: February 14, 2012
Last verified: February 2012
In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients.
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- viral load compliance [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- statistical analysis of MOS HIV [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
all patients would received enfuvirtide and and optimised background
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All patients HIV1 infected in virological failure (viral load > 50 copies/ml) by lack of compliance,old of more than 18 years, who never received enfuvirted and without opportunistic infection, yet treated by almost one molecule of each group.
- virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status.
- hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress
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: NCT00937729
|Rouen, France, 76031 |
University Hospital, Rouen
||CHU Hôpitaux de Rouen
No publications provided
||University Hospital, Rouen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 10, 2009
||February 14, 2012
||France: Institutional Ethical Committee
Keywords provided by University Hospital, Rouen:
uncompliant patients with virological failure
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action