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: October 20, 2014
Last verified: October 2014

May 16, 2006
October 20, 2014
February 2006
September 2007   (final data collection date for primary outcome measure)
Number and percentage of patients with plasma HIV-1 RNA <50 copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Number and % of patients with plasma HIV-1 RNA <50 copies/mL at week 24
Complete list of historical versions of study NCT00326963 on ClinicalTrials.gov Archive Site
  • Adherence, ISRs, premature discontinuations, SAEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 ]
Plasma HIV-1 RNA <50 copies/mL at weeks 4 and 12, and <400 copies/mL at weeks 4, 12 and 24; change from baseline in plasma RNA and CD4 at weeks 4, 12 and 24; adherence; ISRs; premature discontinuations; SAEs
Not Provided
Not Provided
 
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Background ARVs
    As prescribed
  • Drug: PI
    As prescribed
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid
Experimental: 1
Interventions:
  • Drug: Background ARVs
  • Drug: PI
  • Drug: enfuvirtide [Fuzeon]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00326963
ML19712
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Trimeris
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP