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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00326963




Registration number
NCT00326963
Ethics application status
Date submitted
16/05/2006
Date registered
17/05/2006
Date last updated
16/08/2016

Titles & IDs
Public title
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
Scientific title
A Multicenter, Open-label Study Evaluating the Safety and Efficacy of a New Protease Inhibitor (Darunavir) With Fuzeon® (Enfuvirtide) Plus Background Antiretroviral Regimen in HIV-1 Infected, Triple-class Treatment-experienced Patients
Secondary ID [1] 0 0
ML19712
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Background ARVs
Treatment: Drugs - PI
Treatment: Drugs - enfuvirtide [Fuzeon]

Experimental: Enfuvirtide+PI+ARV's - Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).


Treatment: Drugs: Background ARVs
As prescribed

Treatment: Drugs: PI
As prescribed

Treatment: Drugs: enfuvirtide [Fuzeon]
90mg sc bid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Timepoint [1] 0 0
Week 4 and 12
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Timepoint [2] 0 0
Week 4 and 12
Secondary outcome [3] 0 0
Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Timepoint [3] 0 0
Weeks 4, 12, and 24
Secondary outcome [4] 0 0
Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Timepoint [4] 0 0
Weeks 4, 12, and 24
Secondary outcome [5] 0 0
Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
Timepoint [5] 0 0
Baseline (Day 1), Weeks 4, 12, and 24
Secondary outcome [6] 0 0
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Timepoint [6] 0 0
Up to Week 28
Secondary outcome [7] 0 0
Change From Baseline in CD4+ Lymphocyte Count
Timepoint [7] 0 0
Baseline (Day 1), Weeks 4, 12, and 24
Secondary outcome [8] 0 0
Number of Participants Meeting Virologic Failure Criteria
Timepoint [8] 0 0
Weeks 12 and 24
Secondary outcome [9] 0 0
Percentage of Participants Meeting Virologic Failure Criteria
Timepoint [9] 0 0
Weeks 12 and 24
Secondary outcome [10] 0 0
Number of Participants Adhering to Enfuvirtide (ENF)
Timepoint [10] 0 0
Weeks 4, 12, and 24
Secondary outcome [11] 0 0
Percentage of Participants Adhering to ENF
Timepoint [11] 0 0
Weeks 4, 12, and 24
Secondary outcome [12] 0 0
Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Timepoint [12] 0 0
Week 1 to Week 24
Secondary outcome [13] 0 0
Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Timepoint [13] 0 0
Week 1 to Week 24
Secondary outcome [14] 0 0
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Timepoint [15] 0 0
Up to Week 24

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* females who are pregnant or breast-feeding;
* evidence of active, untreated opportunistic infection;
* malignancy requiring chemotherapy or radiotherapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Carlton
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- South Yarra
Recruitment hospital [6] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment postcode(s) [5] 0 0
3141 - South Yarra
Recruitment postcode(s) [6] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Trimeris
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00326963