BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1. - Full Text View

Sponsors and Collaborators:	Hoffmann-La Roche Trimeris
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00326963

Purpose

This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon] Drug: PI Drug: Background ARVs	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Evaluate the Effect on Viral Load of a New Investigational Protease Inhibitor With Fuzeon Plus a Background Antiretroviral Regimen in Triple-Class Treatment-Experienced Patients With HIV-1 Infection

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Number and percentage of patients with plasma HIV-1 RNA <50 copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma HIV-1 RNA <50 copies/mL [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
Plasma HIV-1 RNA <400 copies/mL [ Time Frame: Weeks 4, 12 and 24 ] [ Designated as safety issue: No ]
Change from baseline in plasma RNA and CD4 [ Time Frame: Weeks 4, 12 and 24 ] [ Designated as safety issue: No ]
Adherence, ISRs, premature discontinuations, SAEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	141
Study Completion Date:	October 2006

Arms	Assigned Interventions
1: Experimental	Drug: enfuvirtide [Fuzeon] 90mg sc bid Drug: PI As prescribed Drug: Background ARVs As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
seropositive for HIV-1;
enrolled in an early access program for a new investigational PI;
naive to Fuzeon, and the investigational PI;
treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).

Exclusion Criteria:

females who are pregnant or breast-feeding;
evidence of active, untreated opportunistic infection;
malignancy requiring chemotherapy or radiotherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326963

Show 40 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Trimeris

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19712
Study First Received:	May 16, 2006
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00326963
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action

Infection
Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009