T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs

June 23, 2005 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Completed

Conditions

HIV Infections

Intervention / Treatment

Drug: Enfuvirtide

Detailed Description

An OB regimen is selected to be initiated at baseline by the physician and patient. The OB regimen is based on the patient's prior treatment history as well as the results from the first screening visit HIV-1 genotypic and phenotypic (GT and PT) resistance testing and prior GT/PT antiretroviral resistance testing (if available). Prior or current laboratory abnormalities, including triglycerides and cholesterol, should also be taken into account when selecting the OB regimen. Patients are stratified with respect to the following: 1) screening viral load (less than 40,000 or 40,000 or more copies/ml); and 2) number of allowed investigational antiretrovirals (0, 1, or 2). Patients then are randomized to receive 1 of the following treatments for 48 weeks: OB regimen or OB plus T-20 regimen. Patients are seen for evaluation of efficacy and safety at Weeks 1, 2, and 4, every 4 weeks through Week 24, and then every 8 weeks through Week 48. In addition, efficacy only is evaluated at Weeks 6, 10, and 14. Patients also may be seen at additional visits during the study for plasma HIV-1 RNA measurements to potentially confirm virological failure.

Patients initially randomized to the OB arm who meet the criteria for virological failure and who switch to OB plus T-20 after Week 8 are followed under a new ("switch") schedule of assessments. Patients are encouraged to change their OB regimen at the time of switch.

Patients initially randomized to the OB plus T-20 arm who meet the criteria for virological failure may continue to receive OB plus T-20 if the patient and the physician feel that there is sufficient benefit. Patients are encouraged to change their OB regimen after Week 8 if they choose to continue on OB plus T-20 despite meeting the criteria for virological failure.

Patients on OB or OB plus T-20 arm who meet the criteria for virological failure but who do not wish to either switch to T-20 (for patients initially randomized to OB arm) or continue with T-20 (for patients initially randomized to OB plus T-20) are allowed to remain in the study for a maximum of 1 month.

At the end of the 48 weeks of treatment, patients are allowed to participate in 1 of the following treatment extensions: a) roll-over and receive OB plus T-20 (for patients receiving OB alone); or b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for a maximum of an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed for a maximum of 100 weeks from their initial baseline visit date.

Study Type

Interventional

Enrollment

525

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Carlton, Australia
    - Carlton Clinic
  - Darlinghurst, Australia
    - Holdsworth House General Practice
  - Darlinghurst, Australia
    - Saint Vincent's Hosp
  - Herston, Australia
    - Royal Brisbane Hosp
  - Prahan, Australia
    - Alfred Hosp
  - South Yarra, Australia
    - Prahran Market Clinic
  - Sydney, Australia
    - Taylors Square Clinic
Belgium
- - Antwerpe, Belgium
    - Inst of Tropical Medicine
  - Brussels, Belgium
    - CHU Saint Pierre
  - Leuven, Belgium
    - Uz Gasthuisberg
Germany
- - Bonn, Germany
    - Rheinische Friedrich Wilhelms Universitaet Medizinische
  - Frankfurt, Germany
    - Klinikum Der Johann Wolfgang Goethe Universitat
  - Hamburg, Germany
    - Universitätskrankenhaus Eppendorf
  - Hamburg, Germany
    - Allgemeines Krankenhaus St Georg
Italy
- - Firenze, Italy
    - UO Malattie Infettive
  - Milano, Italy
    - Clinica Malattie Infettive
  - Torino, Italy
    - Ospedale Amedeo di Savoia
Netherlands
- - Amsterdam, Netherlands
    - Natac Med Centre
  - CX Utrecht, Netherlands
    - Univ Medical Center Utrecht
Spain
- - Barcelona, Spain
    - Hospital Germans Trias i Pujol
  - Madrid, Spain
    - Hosp La Paz
  - Valencia, Spain
    - Hospital General Universitario
Sweden
- - Malmoe, Sweden
    - University Hospital MAS
  - Stockholm, Sweden
    - Karolinska hospital
  - Stockholm, Sweden
    - Venhalsan Soder Hosp
Switzerland
- - Basel, Switzerland
    - Univ Hosp Basel / Med Outpatient Dept
  - Geneve, Switzerland
    - Hopital cantonal / Div des maladies infectieuses
  - Lausanne, Switzerland
    - CHUV
  - Zurich, Switzerland
    - Universitatsspital Zurich
United Kingdom
- - Brighton, United Kingdom
    - Brighton Gen Hosp
  - Edinburgh, United Kingdom
    - Western Gen Hosp
  - Liverpool, United Kingdom
    - Royal Liverpool Univ Hosp
  - London, United Kingdom
    - King's College Hospital
  - London, United Kingdom
    - Chelsea and Westminster Hosp
  - London, United Kingdom
    - Royal Free Hosp
  - London, United Kingdom
    - Univ College London Med School
  - Manchester, United Kingdom
    - North Manchester Gen Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Trimeris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 21, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

295D
T20-302

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