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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00021554




Registration number
NCT00021554
Ethics application status
Date submitted
21/07/2001
Date registered
31/08/2001
Date last updated
24/06/2005

Titles & IDs
Public title
T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
Scientific title
A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Regimen Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)
Secondary ID [1] 0 0
T20-302
Secondary ID [2] 0 0
295D
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

Treatment: Drugs: Enfuvirtide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV infected.

- Are at least 16 years of age.

- Have an HIV-1 RNA of at least 5,000 copies/ml.

- Have received anti-HIV drugs for at least 3 months and/or have written records of
resistance to at least 1 member of each of the 3 classes of anti-HIV drugs (nucleoside
reverse transcriptase inhibitors [NRTIs], nonnucleoside reverse transcriptase
inhibitors [NNRTIs], and protease inhibitors [PIs]). Resistance to NNRTIs may not be
required in certain cases.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Carlton Clinic - Carlton
Recruitment hospital [2] 0 0
Holdsworth House General Practice - Darlinghurst
Recruitment hospital [3] 0 0
Saint Vincent's Hosp - Darlinghurst
Recruitment hospital [4] 0 0
Royal Brisbane Hosp - Herston
Recruitment hospital [5] 0 0
Alfred Hosp - Prahan
Recruitment hospital [6] 0 0
Prahran Market Clinic - South Yarra
Recruitment hospital [7] 0 0
Taylors Square Clinic - Sydney
Recruitment postcode(s) [1] 0 0
- Carlton
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Prahan
Recruitment postcode(s) [5] 0 0
- South Yarra
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpe
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Germany
State/province [4] 0 0
Bonn
Country [5] 0 0
Germany
State/province [5] 0 0
Frankfurt
Country [6] 0 0
Germany
State/province [6] 0 0
Hamburg
Country [7] 0 0
Italy
State/province [7] 0 0
Firenze
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Italy
State/province [9] 0 0
Torino
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
Netherlands
State/province [11] 0 0
CX Utrecht
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
Spain
State/province [14] 0 0
Valencia
Country [15] 0 0
Sweden
State/province [15] 0 0
Malmoe
Country [16] 0 0
Sweden
State/province [16] 0 0
Stockholm
Country [17] 0 0
Switzerland
State/province [17] 0 0
Basel
Country [18] 0 0
Switzerland
State/province [18] 0 0
Geneve
Country [19] 0 0
Switzerland
State/province [19] 0 0
Lausanne
Country [20] 0 0
Switzerland
State/province [20] 0 0
Zurich
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Brighton
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Edinburgh
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Liverpool
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Manchester

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
The purpose of this study is to show if a dose of T-20 added to an anti-HIV combination
(chosen specifically for each patient) lowers viral load by at least a certain level after 24
weeks as compared to an anti-HIV combination (chosen specifically for each patient) alone.
Another purpose is to show if the patient response to T-20 will be maintained for 48 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00021554
Trial related presentations / publications
Lazzarin A, Clotet B, Cooper D, Reynes J, Arasteh K, Nelson M, Katlama C, Stellbrink HJ, Delfraissy JF, Lange J, Huson L, DeMasi R, Wat C, Delehanty J, Drobnes C, Salgo M; TORO 2 Study Group. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003 May 29;348(22):2186-95. doi: 10.1056/NEJMoa035211.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/ct2/show/NCT00021554