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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00021554

Collaborator

Trimeris (Industry)

525

Enrollment

Locations

14.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Enfuvirtide	Phase 3

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 Design

Study Type:

Interventional

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)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Carlton Clinic	Carlton	Australia
2	Holdsworth House General Practice	Darlinghurst	Australia
3	Saint Vincent's Hosp	Darlinghurst	Australia
4	Royal Brisbane Hosp	Herston	Australia
5	Alfred Hosp	Prahan	Australia
6	Prahran Market Clinic	South Yarra	Australia
7	Taylors Square Clinic	Sydney	Australia
8	Inst of Tropical Medicine	Antwerpe	Belgium
9	CHU Saint Pierre	Brussels	Belgium
10	UZ Gasthuisberg	Leuven	Belgium
11	Rheinische Friedrich Wilhelms Universitaet Medizinische	Bonn	Germany
12	Klinikum Der Johann Wolfgang Goethe Universitat	Frankfurt	Germany
13	Allgemeines Krankenhaus St Georg	Hamburg	Germany
14	Universitatskrankenhaus Eppendorf	Hamburg	Germany
15	UO Malattie Infettive	Firenze	Italy
16	Clinica Malattie Infettive	Milano	Italy
17	Ospedale Amedeo di Savoia	Torino	Italy
18	Natac Med Centre	Amsterdam	Netherlands
19	Univ Medical Center Utrecht	CX Utrecht	Netherlands
20	Hospital Germans Trias I Pujol	Barcelona	Spain
21	Hosp La Paz	Madrid	Spain
22	Hospital General Universitario	Valencia	Spain
23	University Hospital Mas	Malmoe	Sweden
24	Karolinska Hospital	Stockholm	Sweden
25	Venhalsan Soder Hosp	Stockholm	Sweden
26	Univ Hosp Basel / Med Outpatient Dept	Basel	Switzerland
27	Hopital cantonal / Div des maladies infectieuses	Geneve	Switzerland
28	CHUV	Lausanne	Switzerland
29	Universitatsspital Zurich	Zurich	Switzerland
30	Brighton Gen Hosp	Brighton	United Kingdom
31	Western Gen Hosp	Edinburgh	United Kingdom
32	Royal Liverpool Univ Hosp	Liverpool	United Kingdom
33	Chelsea and Westminster Hosp	London	United Kingdom
34	King's College Hospital	London	United Kingdom
35	Royal Free Hosp	London	United Kingdom
36	Univ College London Med School	London	United Kingdom
37	North Manchester Gen Hosp	Manchester	United Kingdom