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.

Sponsors and Collaborators: Hoffmann-La Roche
Trimeris
Information provided by: AIDS Clinical Trials Information Service

Purpose

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)

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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).

Location Information


Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  352942050,  United States

Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85006,  United States

California
      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

Colorado
      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

Florida
      Steinhart Medical Associates, Miami,  Florida,  33133,  United States

      IDC Research Initiative, Altamonte Springs,  Florida,  32701,  United States

Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States

Illinois
      Trevor Slom, Chicago,  Illinois,  60611,  United States

Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States

Massachusetts
      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

Minnesota
      Regions Hosp, St. Paul,  Minnesota,  55101,  United States

New York
      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

North Carolina
      Univ of North Carolina / SOCA, Chapel Hill,  North Carolina,  275997030,  United States

Ohio
      Univ of Cincinnati, Cincinnati,  Ohio,  452670405,  United States

      Case Western Reserve Univ / AIDS Clinical Trials Unit, Cleveland,  Ohio,  44106,  United States

Oregon
      Oregon Health Sciences Univ, Portland,  Oregon,  97201,  United States

Pennsylvania
      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

Tennessee
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  37212,  United States

Texas
      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

Washington
      Univ of Washington / AIDS Clinical Trial Unit, Seattle,  Washington,  98104,  United States

      Vancouver Clinic, Vancouver,  Washington,  98664,  United States

Canada, Ontario
      Toronto Gen Hosp, Toronto,  Ontario,  Canada

Canada, Quebec
      Clinique Medicale L'Actuele, Montreal,  Quebec,  Canada

      Centre Hospitalier de la Universite de Montreal (CHUM), Montreal,  Quebec,  Canada

More Information

Publications

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.

Study ID Numbers:  295C; T20-301
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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