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

NCT ID: NCT00021554

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

HIV Infections

Keywords

HIV-1; Drug Therapy, Combination; HIV Protease Inhibitors; RNA, Viral; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; pentafuside

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

Enfuvirtide

Intervention Type: DRUG

Eligibility 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 Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trimeris

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

Australia; Belgium; Germany; Italy; Netherlands; Spain; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 12773645 (View on PubMed)

Other Identifiers

T20-302

Identifier Type: -

Identifier Source: secondary_id

295D

Identifier Type: -

Identifier Source: org_study_id