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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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche , Trimeris
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 525

Location and Contact Information:

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

San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

Steinhart Medical Associates
Miami,  Florida,  33133
United States
 

Trevor Slom
Chicago,  Illinois,  60611
United States
 

Toronto Gen Hosp
Toronto,  Ontario, 
Canada
 

Pennsylvania Oncology and Hematology Associates
Philadelphia,  Pennsylvania,  19106
United States
 

Peter Tsang
New York City,  New York,  10011
United States
 

IDC Research Initiative
Altamonte Springs,  Florida,  32701
United States
 

Oregon Health Sciences Univ
Portland,  Oregon,  97201
United States
 

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

Albany Med College
Albany,  New York,  12208
United States
 

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

Vanderbilt Univ Med Ctr
Nashville,  Tennessee,  37212
United States
 

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

Nicholas Bellos
Dallas,  Texas,  75246
United States
 

Pacific Oaks Med Group
Beverly Hills,  California,  90211
United States
 

Univ of California, San Diego
San Diego,  California,  92103
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Clinique Medicale L'Actuele
Montreal,  Quebec, 
Canada
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

AIDS Healthcare Foundation
Los Angeles,  California,  900276069
United States
 

Phoenix Body Positive
Phoenix,  Arizona,  85006
United States
 

Univ of Pittsburgh
Pittsburgh,  Pennsylvania,  15213
United States
 

Massachusetts Gen Hosp
Boston,  Massachusetts,  02114
United States
 

Univ of Texas / Thomas Street Clinic
Houston,  Texas,  77030
United States
 

San Francisco VA Med Ctr
San Francisco,  California,  94121
United States
 

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

New England Med Ctr
Boston,  Massachusetts,  02111
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  100323784
United States
 

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

Whitman Walker Clinic/Elizabeth Taylor Med Ctr
Washington D.C.,  District of Columbia,  20009
United States
 

Regions Hosp
St. Paul,  Minnesota,  55101
United States
 

Community Research Initiative of New England
Brookline,  Massachusetts,  02445
United States
 

MCP Hahnemann Univ
Philadelphia,  Pennsylvania,  19102
United States
 

Univ of Texas Med Branch
Galveston,  Texas,  77555
United States
 

Vancouver Clinic
Vancouver,  Washington,  98664
United States
 


Additional Information:
Study ID Numbers:
  295C;  T20-301
Study Start Date: 
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008528

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5. The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients

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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

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