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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Collaborator: |
Trimeris |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00008528 |
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Enfuvirtide |
Phase III |
| 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) |
| Estimated 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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 352942050 | |
| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Pacific Oaks Med Group | |
| Beverly Hills, California, United States, 90211 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| San Francisco VA Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Univ of California, San Diego | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Whitman Walker Clinic/Elizabeth Taylor Med Ctr | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| Steinhart Medical Associates | |
| Miami, Florida, United States, 33133 | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Trevor Slom | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| Massachusetts Gen Hosp | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Regions Hosp | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, New York | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 100323784 | |
| Albany Med College | |
| Albany, New York, United States, 12208 | |
| Peter Tsang | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Univ of North Carolina / SOCA | |
| Chapel Hill, North Carolina, United States, 275997030 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| Case Western Reserve Univ / AIDS Clinical Trials Unit | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Oregon Health Sciences Univ | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Pennsylvania Oncology and Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| MCP Hahnemann Univ | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Univ of Texas / Thomas Street Clinic | |
| Houston, Texas, United States, 77030 | |
| Nicholas Bellos | |
| Dallas, Texas, United States, 75246 | |
| United States, Washington | |
| Univ of Washington / AIDS Clinical Trial Unit | |
| Seattle, Washington, United States, 98104 | |
| Vancouver Clinic | |
| Vancouver, Washington, United States, 98664 | |
| 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
| Study ID Numbers: | 295C, T20-301 |
| Study First Received: | January 12, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00008528 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Therapy, Combination Drug Resistance, Microbial RNA, Viral |
Membrane Fusion Anti-HIV Agents Viral Load |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Enfuvirtide Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections HIV Fusion Inhibitors |