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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00461266




Registration number
NCT00461266
Ethics application status
Date submitted
16/04/2007
Date registered
17/04/2007
Date last updated
24/08/2016

Titles & IDs
Public title
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
Scientific title
A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression
Secondary ID [1] 0 0
ML19355
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 - enfuvirtide [Fuzeon]
Treatment: Drugs - Antiretroviral therapy

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: enfuvirtide [Fuzeon]
90mg sc bid

Treatment: Drugs: Antiretroviral therapy
As prescribed
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in CD4 cell count from baseline
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change in HIV RNA from baseline
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Change in HIV RNA and CD4 cell count
Timepoint [2] 0 0
Weeks 24-48
Secondary outcome [3] 0 0
Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.
Timepoint [3] 0 0
Throughout study

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* documented chronic HIV infection;
* currently receiving a stable antiretroviral regimen;
* CD4 cell count <250 cells/mm3;
* HIV RNA viral load <400 copies/mL for >12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior exposure to Fuzeon;
* prior non-adherence to antiretroviral treatment regimens;
* active opportunistic infection;
* currently taking, or anticipated to take during the study, any immunomodulator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Carlton
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Miami
Recruitment hospital [5] 0 0
- Perth
Recruitment hospital [6] 0 0
- South Yarra
Recruitment hospital [7] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Carlton
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Miami
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- South Yarra
Recruitment postcode(s) [7] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

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 not provided in https://clinicaltrials.gov/study/NCT00461266