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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
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 approximately 120 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00326963
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00326963