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

This study has been completed.

Sponsors and Collaborators: Hoffmann-La Roche
Trimeris
Information provided by: AIDS Clinical Trials Information Service

Purpose

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.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Enfuvirtide
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Parallel Assignment

Official 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)

Further Study Details: 

Expected Total Enrollment:  525

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.

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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.

Location Information


Australia
      Saint Vincent's Hosp, Darlinghurst,  Australia

      Alfred Hosp, Prahan,  Australia

      Royal Brisbane Hosp, HERSTON,  Australia

      Prahran Market Clinic, South Yarra,  Australia

      Holdsworth House General Practice, Darlinghurst,  Australia

      Carlton Clinic, Carlton,  Australia

      Taylors Square Clinic, Sydney,  Australia

Belgium
      CHU Saint Pierre, Brussels,  Belgium

      Inst of Tropical Medicine, Antwerpe,  Belgium

      UZ Gasthuisberg, Leuven,  Belgium

Germany
      Allgemeines Krankenhaus St Georg, Hamburg,  Germany

      Rheinische Friedrich Wilhelms Universitaet Medizinische, Bonn,  Germany

      Klinikum Der Johann Wolfgang Goethe Universitat, Frankfurt,  Germany

      Universitatskrankenhaus Eppendorf, Hamburg,  Germany

Italy
      Clinica Malattie Infettive, Milano,  Italy

      UO Malattie Infettive, Firenze,  Italy

      Ospedale Amedeo di Savoia, Torino,  Italy

Netherlands
      Natac Med Centre, Amsterdam,  Netherlands

      Univ Medical Center Utrecht, CX Utrecht,  Netherlands

Spain
      Hosp La Paz, Madrid,  Spain

      Hospital Germans Trias I Pujol, Barcelona,  Spain

      Hospital General Universitario, Valencia,  Spain

Sweden
      Venhalsan Soder Hosp, Stockholm,  Sweden

      University Hospital Mas, Malmoe,  Sweden

      Karolinska Hospital, Stockholm,  Sweden

Switzerland
      Universitatsspital Zurich, Zurich,  Switzerland

      Hopital cantonal / Div des maladies infectieuses, Geneve,  Switzerland

      Univ Hosp Basel / Med Outpatient Dept, Basel,  Switzerland

      CHUV, Lausanne,  Switzerland

United Kingdom
      Royal Free Hosp, London,  United Kingdom

      Royal Liverpool Univ Hosp, Liverpool,  United Kingdom

      Brighton Gen Hosp, Brighton,  United Kingdom

      King's College Hospital, London,  United Kingdom

      Chelsea and Westminster Hosp, London,  United Kingdom

      Western Gen Hosp, Edinburgh,  United Kingdom

      Univ College London Med School, London,  United Kingdom

      North Manchester Gen Hosp, Manchester,  United Kingdom

More Information

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. 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.

Study ID Numbers:  295D; T20-302
Record last reviewed:  May 2002
Last Updated:  October 13, 2004
Record first received:  July 21, 2001
ClinicalTrials.gov Identifier:  NCT00021554
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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