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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

NCT ID: NCT00008528

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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HIV-1 Drug Therapy, Combination Drug Resistance, Microbial RNA, Viral Membrane Fusion Anti-HIV Agents Viral Load

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Enfuvirtide

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trimeris

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Phoenix Body Positive

Phoenix, Arizona, United States

Site Status

Pacific Oaks Med Group

Beverly Hills, California, United States

Site Status

AIDS Healthcare Foundation

Los Angeles, California, United States

Site Status

Univ of California, San Diego

San Diego, California, United States

Site Status

San Francisco Gen Hosp

San Francisco, California, United States

Site Status

San Francisco VA Med Ctr

San Francisco, California, United States

Site Status

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Site Status

Whitman Walker Clinic/Elizabeth Taylor Med Ctr

Washington D.C., District of Columbia, United States

Site Status

IDC Research Initiative

Altamonte Springs, Florida, United States

Site Status

Steinhart Medical Associates

Miami, Florida, United States

Site Status

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Site Status

Trevor Slom

Chicago, Illinois, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

New England Med Ctr

Boston, Massachusetts, United States

Site Status

Massachusetts Gen Hosp

Boston, Massachusetts, United States

Site Status

Community Research Initiative of New England

Brookline, Massachusetts, United States

Site Status

Regions Hosp

Saint Paul, Minnesota, United States

Site Status

Albany Med College

Albany, New York, United States

Site Status

Peter Tsang

New York, New York, United States

Site Status

Columbia Presbyterian Med Ctr

New York, New York, United States

Site Status

Univ of North Carolina / SOCA

Chapel Hill, North Carolina, United States

Site Status

Univ of Cincinnati

Cincinnati, Ohio, United States

Site Status

Case Western Reserve Univ / AIDS Clinical Trials Unit

Cleveland, Ohio, United States

Site Status

Oregon Health Sciences Univ

Portland, Oregon, United States

Site Status

MCP Hahnemann Univ

Philadelphia, Pennsylvania, United States

Site Status

Pennsylvania Oncology and Hematology Associates

Philadelphia, Pennsylvania, United States

Site Status

Univ of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt Univ Med Ctr

Nashville, Tennessee, United States

Site Status

Nicholas Bellos

Dallas, Texas, United States

Site Status

Univ of Texas Med Branch

Galveston, Texas, United States

Site Status

Univ of Texas / Thomas Street Clinic

Houston, Texas, United States

Site Status

Univ of Washington / AIDS Clinical Trial Unit

Seattle, Washington, United States

Site Status

Vancouver Clinic

Vancouver, Washington, United States

Site Status

Toronto Gen Hosp

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de la Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status

Clinique Medicale L'Actuele

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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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. doi: 10.1056/NEJMoa035026. Epub 2003 Mar 13.

Reference Type BACKGROUND
PMID: 12637625 (View on PubMed)

Other Identifiers

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T20-301

Identifier Type: -

Identifier Source: secondary_id

295C

Identifier Type: -

Identifier Source: org_study_id