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)
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
Sponsors
Source
NIH AIDS Clinical Trials Information Service
Brief 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.
Detailed 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.
Overall Status
Completed
Start Date
N/A
Completion Date
N/A
Primary Completion Date
N/A
Phase
Phase 3
Study Type
Interventional
Enrollment
525
Condition
Intervention
Eligibility
Criteria
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).
Gender
All
Minimum Age
16 Years
Maximum Age
N/A
Healthy Volunteers
No
Location
Facility |
|
Univ of Alabama at Birmingham Birmingham Alabama 352942050 United States |
|
Phoenix Body Positive Phoenix Arizona 85006 United States |
|
Pacific Oaks Med Group Beverly Hills California 90211 United States |
|
AIDS Healthcare Foundation Los Angeles California 900276069 United States |
|
Univ of California, San Diego San Diego California 92103 United States |
|
San Francisco Gen Hosp San Francisco California 94110 United States |
|
San Francisco VA Med Ctr San Francisco California 94121 United States |
|
Univ of Colorado Health Sciences Ctr Denver Colorado 80262 United States |
|
Whitman Walker Clinic/Elizabeth Taylor Med Ctr Washington District of Columbia 20009 United States |
|
IDC Research Initiative Altamonte Springs Florida 32701 United States |
|
Steinhart Medical Associates Miami Florida 33133 United States |
|
AIDS Research Consortium of Atlanta Atlanta Georgia 30308 United States |
|
Trevor Slom Chicago Illinois 60611 United States |
|
Indiana Univ Hosp Indianapolis Indiana 462025250 United States |
|
New England Med Ctr Boston Massachusetts 02111 United States |
|
Massachusetts Gen Hosp Boston Massachusetts 02114 United States |
|
Community Research Initiative of New England Brookline Massachusetts 02445 United States |
|
Regions Hosp St. Paul Minnesota 55101 United States |
|
Albany Med College Albany New York 12208 United States |
|
Peter Tsang New York New York 10011 United States |
|
Columbia Presbyterian Med Ctr New York New York 100323784 United States |
|
Univ of North Carolina / SOCA Chapel Hill North Carolina 275997030 United States |
|
Univ of Cincinnati Cincinnati Ohio 452670405 United States |
|
Case Western Reserve Univ / AIDS Clinical Trials Unit Cleveland Ohio 44106 United States |
|
Oregon Health Sciences Univ Portland Oregon 97201 United States |
|
MCP Hahnemann Univ Philadelphia Pennsylvania 19102 United States |
|
Pennsylvania Oncology and Hematology Associates Philadelphia Pennsylvania 19106 United States |
|
Univ of Pittsburgh Pittsburgh Pennsylvania 15213 United States |
|
Vanderbilt Univ Med Ctr Nashville Tennessee 37212 United States |
|
Nicholas Bellos Dallas Texas 75246 United States |
|
Univ of Texas Med Branch Galveston Texas 77555 United States |
|
Univ of Texas / Thomas Street Clinic Houston Texas 77030 United States |
|
Univ of Washington / AIDS Clinical Trial Unit Seattle Washington 98104 United States |
|
Vancouver Clinic Vancouver Washington 98664 United States |
|
Toronto Gen Hosp Toronto Ontario Canada |
|
Centre Hospitalier de la Universite de Montreal (CHUM) Montreal Quebec Canada |
|
Clinique Medicale L'Actuele Montreal Quebec Canada |
Location Countries
Country
Canada
United States
Verification Date
2001-06-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
T20-301
Intervention Browse
Mesh Term
Enfuvirtide
Firstreceived Results Date
N/A
Reference
Citation
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.
PMID
12637625
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Study First Submitted
January 12, 2001
Study First Submitted Qc
August 30, 2001
Study First Posted
August 31, 2001
Last Update Submitted
June 23, 2005
Last Update Submitted Qc
June 23, 2005
Last Update Posted
June 24, 2005
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.