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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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)

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Hoffmann-La Roche

Ethics approval
Ethics application status

Brief summary
This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral
regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an
HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon
90mg bid sc in addition to their current antiretroviral therapy, or to continue their current
antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the
target sample size is <100 individuals.
Trial website
Trial related presentations / publications
Public notes

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