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

HIV Infections Clinical Trial

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 Therapy 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00008528
• Other study ID #: 295C
• Secondary ID: T20-301
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2001
• Last updated: June 23, 2005

Study information

• Verified date: June 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.

Description:

Eligible patients remain on their pre-study regimen until baseline. An OB regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening GT/PT antiretroviral resistance testing, and any prior GT/PT antiretroviral resistance (if available). The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. Patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. Patients are randomized to receive 1 of the following 2 treatments for 48 weeks: OB or OB plus T-20. Patients are followed to assess viral load, safety, antiretroviral resistance, T-20 pharmacokinetics, and quality of life. At the end of 48 weeks of treatment patients are allowed to (a) roll over and receive OB plus T-20 (for patients receiving OB regimen alone) or (b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for 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 in this study for a maximum of 100 weeks from their initial baseline visit date.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-infected.

• Are at least 16 years old (have consent of parent or guardian if under 18).

• Have a viral load (level of HIV in the blood) of 5,000 copies/ml or more.

• Have received anti-HIV drugs for at least 6 months and/or have shown resistance to each of the 3 types of anti-HIV drugs as follows: nucleoside reverse transcriptase inhibitors (resistant to 1 or more); nonnucleoside reverse transcriptase inhibitors (resistant to 1 or more); and protease inhibitors (resistant to 2 or more, taken either together or 1 after the other for at least 6 months total).

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Enfuvirtide

Locations

Country	Name	City	State
Canada	Centre Hospitalier de la Universite de Montreal (CHUM)	Montreal	Quebec
Canada	Clinique Medicale L'Actuele	Montreal	Quebec
Canada	Toronto Gen Hosp	Toronto	Ontario
United States	Albany Med College	Albany	New York
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts Gen Hosp	Boston	Massachusetts
United States	New England Med Ctr	Boston	Massachusetts
United States	Community Research Initiative of New England	Brookline	Massachusetts
United States	Univ of North Carolina / SOCA	Chapel Hill	North Carolina
United States	Trevor Slom	Chicago	Illinois
United States	Univ of Cincinnati	Cincinnati	Ohio
United States	Case Western Reserve Univ / AIDS Clinical Trials Unit	Cleveland	Ohio
United States	Nicholas Bellos	Dallas	Texas
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Univ of Texas Med Branch	Galveston	Texas
United States	Univ of Texas / Thomas Street Clinic	Houston	Texas
United States	Indiana Univ Hosp	Indianapolis	Indiana
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Steinhart Medical Associates	Miami	Florida
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	Peter Tsang	New York	New York
United States	MCP Hahnemann Univ	Philadelphia	Pennsylvania
United States	Pennsylvania Oncology and Hematology Associates	Philadelphia	Pennsylvania
United States	Phoenix Body Positive	Phoenix	Arizona
United States	Univ of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences Univ	Portland	Oregon
United States	Univ of California, San Diego	San Diego	California
United States	San Francisco Gen Hosp	San Francisco	California
United States	San Francisco VA Med Ctr	San Francisco	California
United States	Univ of Washington / AIDS Clinical Trial Unit	Seattle	Washington
United States	Regions Hosp	St. Paul	Minnesota
United States	Vancouver Clinic	Vancouver	Washington
United States	Whitman Walker Clinic/Elizabeth Taylor Med Ctr	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Lalezari JP, Henry K, O'Hearn M, Montaner JS, Piliero PJ, Trottier B, Walmsley S, Cohen C, Kuritzkes DR, Eron JJ Jr, Chung J, DeMasi R, Donatacci L, Drobnes C, Delehanty J, Salgo M; TORO 1 Study Group. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003 May 29;348(22):2175-85. Epub 2003 Mar 13. Erratum in: N Engl J Med. 2003 Sep 11;349(11):1100. — View Citation