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)

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by (Responsible Party):

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT00937729

First received: July 10, 2009

Last updated: February 14, 2012

Last verified: February 2012

History of Changes

Purpose

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.

Condition
HIV1 Infection HIV Infections


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

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 ]


Enrollment:	4
Study Start Date:	June 2009
Study Completion Date:	December 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
enfuvirtide all patients would received enfuvirtide and and optimised background

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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

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: NCT00937729

Locations


France
Borsa-Lebas
Rouen, France, 76031

Sponsors and Collaborators

University Hospital, Rouen

Hoffmann-La Roche

Investigators


Principal Investigator:	BORSA-LEBAS Françoise	CHU Hôpitaux de Rouen

More Information

No publications provided


Responsible Party:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00937729 History of Changes
Other Study ID Numbers:	2008/122/HP
Study First Received:	July 10, 2009
Last Updated:	February 14, 2012
Health Authority:	France: Institutional Ethical Committee

Keywords provided by University Hospital, Rouen:


uncompliant patients with virological failure Treatment experienced

Additional relevant MeSH terms:


Enfuvirtide Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents	HIV Fusion Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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