Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Assessment method [1] 0 0
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results \<50 copies/mL is reported.
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Assessment method [2] 0 0
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results \<50 copies/mL is reported.
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Assessment method [1] 0 0
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results \<50 copies/mL is reported.
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
Assessment method [2] 0 0
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results \<50 copies/mL is reported.
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
Assessment method [3] 0 0
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results \<400 copies/mL is reported.
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
Assessment method [4] 0 0
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results \<400 copies/mL is reported.
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
Assessment method [5] 0 0
Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) - (plasma HIV-1 RNA count at baseline).
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)
Assessment method [6] 0 0
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.
Timepoint [6] 0 0
Up to Week 28
Secondary outcome [7] 0 0
Change From Baseline in CD4+ Lymphocyte Count
Assessment method [7] 0 0
Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) - (CD4+ count at baseline).
Timepoint [7] 0 0
Baseline (Day 1), Weeks 4, 12, and 24
Secondary outcome [8] 0 0
Number of Participants Meeting Virologic Failure Criteria
Assessment method [8] 0 0
The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA \<50 copies/mL at Week 4, and HIV-RNA \> 50 copies/mL at Week 12, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA \<50 copies/mL at week 12, and HIV-RNA \>50 copies/mL at week 24/early discontinuation, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA \>50 copies/mL at any time up to week 24 and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.
Timepoint [8] 0 0
Weeks 12 and 24
Secondary outcome [9] 0 0
Percentage of Participants Meeting Virologic Failure Criteria
Assessment method [9] 0 0
The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA \<50 copies/mL at Week 4, and HIV-RNA \> 50 copies/mL at Week 12, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA \<50 copies/mL at week 12, and HIV-RNA \>50 copies/mL at week 24/early discontinuation, and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA \>50 copies/mL at any time up to week 24 and HIV-RNA \>50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.
Timepoint [9] 0 0
Weeks 12 and 24
Secondary outcome [10] 0 0
Number of Participants Adhering to Enfuvirtide (ENF)
Assessment method [10] 0 0
Adherence to ENF treatment regimen was calculated using the participant's response to the query on the "Participant Adherence Questionnaire case report form (CRF)" about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = (\[8 - the number of doses missed\] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, =95%, =90% and =85%) at Weeks 4, 12, and 24.
Timepoint [10] 0 0
Weeks 4, 12, and 24
Secondary outcome [11] 0 0
Percentage of Participants Adhering to ENF
Assessment method [11] 0 0
Adherence to ENF treatment regimen was calculated using the participant's response to the query on the "Participant Adherence Questionnaire case report form (CRF)" about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = (\[8 - the number of doses missed\] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, =95%, =90% and =85%) at Weeks 4, 12, and 24.
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
Assessment method [12] 0 0
Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the 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
Assessment method [13] 0 0
Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the 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.
Assessment method [14] 0 0
Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Assessment method [15] 0 0
The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade=3 laboratory toxicities) were noted and presented.
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
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Trimeris
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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