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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: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Background ARVs
Drug: enfuvirtide [Fuzeon]
Drug: PI
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: Background ARVs
As prescribed
Drug: enfuvirtide [Fuzeon]
90mg sc bid
Drug: PI
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
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: NCT00326963

  Show 38 Study Locations
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: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014