T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
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)
2 other identifiers
interventional
525
9 countries
37
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 2002
July 21, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Trimeriscollaborator
Study Sites (37)
Carlton Clinic
Carlton, Australia
Holdsworth House General Practice
Darlinghurst, Australia
Saint Vincent's Hosp
Darlinghurst, Australia
Royal Brisbane Hosp
Herston, Australia
Alfred Hosp
Prahan, Australia
Prahran Market Clinic
South Yarra, Australia
Taylors Square Clinic
Sydney, Australia
Inst of Tropical Medicine
Antwerp, Belgium
CHU Saint Pierre
Brussels, Belgium
UZ Gasthuisberg
Leuven, Belgium
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn, Germany
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt, Germany
Allgemeines Krankenhaus St Georg
Hamburg, Germany
Universitatskrankenhaus Eppendorf
Hamburg, Germany
UO Malattie Infettive
Florence, Italy
Clinica Malattie Infettive
Milan, Italy
Ospedale Amedeo di Savoia
Torino, Italy
Natac Med Centre
Amsterdam, Netherlands
Univ Medical Center Utrecht
CX Utrecht, Netherlands
Hospital Germans Trias I Pujol
Barcelona, Spain
Hosp La Paz
Madrid, Spain
Hospital General Universitario
Valencia, Spain
University Hospital Mas
Malmo, Sweden
Karolinska Hospital
Stockholm, Sweden
Venhalsan Soder Hosp
Stockholm, Sweden
Univ Hosp Basel / Med Outpatient Dept
Basel, Switzerland
Hopital cantonal / Div des maladies infectieuses
Geneva, Switzerland
CHUV
Lausanne, Switzerland
Universitatsspital Zurich
Zurich, Switzerland
Brighton Gen Hosp
Brighton, United Kingdom
Western Gen Hosp
Edinburgh, United Kingdom
Royal Liverpool Univ Hosp
Liverpool, United Kingdom
Chelsea and Westminster Hosp
London, United Kingdom
King's College Hospital
London, United Kingdom
Royal Free Hosp
London, United Kingdom
Univ College London Med School
London, United Kingdom
North Manchester Gen Hosp
Manchester, United Kingdom
Related Publications (1)
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.
PMID: 12773645BACKGROUND