Trial Review

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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
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
https://clinicaltrials.gov/study/NCT00461266
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/NCT00461266