Clinical trial NCT00008528: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Drug Resistance, Microbial
RNA, Viral
Membrane Fusion
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
Collaborators: name: Trimeris
First posted: 2001-08-31
Enrollment: 525
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Beverly Hills
country: United States
facility: Pacific Oaks Med Group
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: San Diego
country: United States
facility: Univ of California, San Diego
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: San Francisco VA Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Washington
country: United States
facility: Whitman Walker Clinic/Elizabeth Taylor Med Ctr
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Trevor Slom
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Gen Hosp
state: Massachusetts
city: Brookline
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: St. Paul
country: United States
facility: Regions Hosp
state: Minnesota
city: Albany
country: United States
facility: Albany Med College
state: New York
city: New York
country: United States
facility: Peter Tsang
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina / SOCA
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve Univ / AIDS Clinical Trials Unit
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences Univ
state: Oregon
city: Philadelphia
country: United States
facility: MCP Hahnemann Univ
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Oncology and Hematology Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
city: Dallas
country: United States
facility: Nicholas Bellos
state: Texas
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
city: Houston
country: United States
facility: Univ of Texas / Thomas Street Clinic
state: Texas
city: Seattle
country: United States
facility: Univ of Washington / AIDS Clinical Trial Unit
state: Washington
city: Vancouver
country: United States
facility: Vancouver Clinic
state: Washington
city: Toronto
country: Canada
facility: Toronto Gen Hosp
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de la Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuele
state: Quebec
Study officials:
References:
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. doi: 10.1056/NEJMoa035026. Epub 2003 Mar 13.