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

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00326963
First received: May 16, 2006
Last updated: April 7, 2014
Last verified: April 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 Start Date: February 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, California
Bakersfield, California, United States, 93301
Beverly Hills, California, United States, 90210
Los Angeles, California, United States, 90027
Los Angeles, California, United States, 90028
Los Angeles, California, United States, 90036
San Francisco, California, United States, 94114
Stanford, California, United States, 94305
Tarzana, California, United States, 91356
United States, Connecticut
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Washington, District of Columbia, United States, 20009
United States, Florida
Fort Lauderdale, Florida, United States, 33334
Orlando, Florida, United States, 32803
Port St Lucie, Florida, United States, 34952
United States, Georgia
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
St Louis, Missouri, United States, 63139
United States, New Jersey
Newark, New Jersey, United States, 07102
Somers Point, New Jersey, United States, 08244
United States, New York
Albany, New York, United States, 12208
New York, New York, United States, 10032
New York, New York, United States, 10003
United States, North Carolina
Huntersville, North Carolina, United States, 28078
United States, Oregon
Portland, Oregon, United States, 97209-2534
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Dallas, Texas, United States, 75246
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77098
Houston, Texas, United States, 77004
United States, Virginia
Annandale, Virginia, United States, 22003
Hampton, Virginia, United States, 23666
Australia
Brisbane, Australia, 4000
Carlton, Australia, 3053
Liverpool, Australia, 2170
Melbourne, Australia, 3181
South Yarra, Australia, 3141
Sydney, Australia, 2010
Sponsors and Collaborators
Hoffmann-La Roche
Trimeris
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00326963     History of Changes
Other Study ID Numbers: ML19712
Study First Received: May 16, 2006
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
HIV Protease Inhibitors
Enfuvirtide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014