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

NCT00937729 | Terminated DMC

• 1 other identifier: 2008/122/HP
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV1 Infection; HIV Infections

Keywords

uncompliant patients with virological failure; Treatment experienced

Outcome Measures

Primary Outcomes (1)

• viral load compliance

  one year

Secondary Outcomes (1)

• statistical analysis of MOS HIV

  one year

Study Arms (1)

enfuvirtide

all patients would received enfuvirtide and and optimised background

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status.

You may not qualify if:

• hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Borsa-Lebas

Rouen, 76031, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• BORSA-LEBAS Françoise

  CHU Hôpitaux de Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

FR (1)