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.
Sponsor:
Collaborator:
Trimeris
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00021554
First received: July 21, 2001
Last updated: June 23, 2005
Last verified: May 2002
  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 Intervention Phase
HIV Infections
Drug: Enfuvirtide
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 525
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021554

  Hide Study Locations
Locations
Australia
Carlton Clinic
Carlton, Australia
Saint Vincent's Hosp
Darlinghurst, Australia
Holdsworth House General Practice
Darlinghurst, Australia
Royal Brisbane Hosp
Herston, Australia
Alfred Hosp
Prahan, Australia
Prahran Market Clinic
South Yarra, Australia
Taylors Square Clinic
Sydney, Australia
Belgium
Inst of Tropical Medicine
Antwerpe, Belgium
CHU Saint Pierre
Brussels, Belgium
UZ Gasthuisberg
Leuven, Belgium
Germany
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
Italy
UO Malattie Infettive
Firenze, Italy
Clinica Malattie Infettive
Milano, Italy
Ospedale Amedeo di Savoia
Torino, Italy
Netherlands
Natac Med Centre
Amsterdam, Netherlands
Univ Medical Center Utrecht
CX Utrecht, Netherlands
Spain
Hospital Germans Trias I Pujol
Barcelona, Spain
Hosp La Paz
Madrid, Spain
Hospital General Universitario
Valencia, Spain
Sweden
University Hospital Mas
Malmoe, Sweden
Karolinska Hospital
Stockholm, Sweden
Venhalsan Soder Hosp
Stockholm, Sweden
Switzerland
Univ Hosp Basel / Med Outpatient Dept
Basel, Switzerland
Hopital cantonal / Div des maladies infectieuses
Geneve, Switzerland
CHUV
Lausanne, Switzerland
Universitatsspital Zurich
Zurich, Switzerland
United Kingdom
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
Royal Free Hosp
London, United Kingdom
King's College Hospital
London, United Kingdom
Univ College London Med School
London, United Kingdom
North Manchester Gen Hosp
Manchester, United Kingdom
Sponsors and Collaborators
Hoffmann-La Roche
Trimeris
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00021554     History of Changes
Other Study ID Numbers: 295D, T20-302
Study First Received: July 21, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
pentafuside

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enfuvirtide
Anti-HIV Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014