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 - Article Fuzeon
Clinical Trial: 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
This study has been completed.
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.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Enfuvirtide ||Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Parallel Assignment
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)
Expected Total Enrollment: 525
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.
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both
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).
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
San Francisco Gen Hosp, San Francisco, California, 94110, United States
AIDS Healthcare Foundation, Los Angeles, California, 900276069, United States
San Francisco VA Med Ctr, San Francisco, California, 94121, United States
Univ of California, San Diego, San Diego, California, 92103, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado, 80262, United States
District of Columbia
Whitman Walker Clinic/Elizabeth Taylor Med Ctr, Washington, District of Columbia, 20009, United States
Steinhart Medical Associates, Miami, Florida, 33133, United States
IDC Research Initiative, Altamonte Springs, Florida, 32701, 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
Community Research Initiative of New England, Brookline, Massachusetts, 02445, United States
Massachusetts Gen Hosp, Boston, Massachusetts, 02114, United States
Regions Hosp, St. Paul, Minnesota, 55101, United States
Columbia Presbyterian Med Ctr, New York, New York, 100323784, United States
Albany Med College, Albany, New York, 12208, United States
Peter Tsang, New York, New York, 10011, 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
Pennsylvania Oncology and Hematology Associates, Philadelphia, Pennsylvania, 19106, United States
MCP Hahnemann Univ, Philadelphia, Pennsylvania, 19102, United States
Univ of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Univ Med Ctr, Nashville, Tennessee, 37212, United States
Univ of Texas Med Branch, Galveston, Texas, 77555, United States
Univ of Texas / Thomas Street Clinic, Houston, Texas, 77030, United States
Nicholas Bellos, Dallas, Texas, 75246, 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
Clinique Medicale L'Actuele, Montreal, Quebec, Canada
Centre Hospitalier de la Universite de Montreal (CHUM), Montreal, Quebec, Canada
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. 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.
Record last reviewed: June 2001
Last Updated: October 13, 2004
Record first received: January 12, 2001
ClinicalTrials.gov Identifier: NCT00008528
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005