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| Sponsors and Collaborators: |
Hoffmann-La Roche Trimeris |
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00002239 |
Purpose
The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Enfuvirtide Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz |
Phase II |
| MedlinePlus related topics: | AIDS AIDS Medicines |
| Drug Information available for: | Abacavir Abacavir sulfate Efavirenz Ritonavir Enfuvirtide VX 478 |
| Study Type: | Interventional |
| Study Design: | Treatment, Pharmacokinetics Study |
| Official Title: | A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults |
| Estimated Enrollment: | 68 |
| Study Start Date: | May 1999 |
Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations| United States, California | |||||
| UCSD | |||||
| San Diego, California, United States, 92103 | |||||
| ViRx Inc | |||||
| San Francisco, California, United States, 94109 | |||||
| Pacific Oaks Research | |||||
| Beverly Hills, California, United States, 90211 | |||||
| UCLA Care Ctr | |||||
| Los Angeles, California, United States, 90095 | |||||
| Quest Clinical Research | |||||
| San Francisco, California, United States, 94115 | |||||
| ViRx Inc | |||||
| Palm Springs, California, United States, 92262 | |||||
| Donald Northfelt | |||||
| Palm Springs, California, United States, 92270 | |||||
| United States, District of Columbia | |||||
| Dupont Circle Physicians Group | |||||
| Washington, District of Columbia, United States, 200091104 | |||||
| United States, Florida | |||||
| Gary Richmond MD | |||||
| Fort Lauderdale, Florida, United States, 33316 | |||||
| IDC Research Initiative | |||||
| Altamonte Springs, Florida, United States, 32701 | |||||
| United States, Georgia | |||||
| AIDS Research Consortium of Atlanta | |||||
| Atlanta, Georgia, United States, 30308 | |||||
| United States, Maryland | |||||
| Johns Hopkins Hosp | |||||
| Baltimore, Maryland, United States, 21287 | |||||
| United States, Missouri | |||||
| Washington Univ School of Medicine | |||||
| St. Louis, Missouri, United States, 63110 | |||||
| United States, New York | |||||
| New York Univ Med Ctr | |||||
| New York, New York, United States, 10016 | |||||
| United States, North Carolina | |||||
| Trimeris Inc | |||||
| Durham, North Carolina, United States, 27707 | |||||
| United States, Oklahoma | |||||
| Associates of Med and Mental Health | |||||
| Tulsa, Oklahoma, United States, 74114 | |||||
| United States, Pennsylvania | |||||
| Univ of Pittsburgh | |||||
| Pittsburgh, Pennsylvania, United States, 15261 | |||||
| Philadelphia FIGHT | |||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Pennsylvania Oncology and Hematology Associates | |||||
| Philadelphia, Pennsylvania, United States, 19106 | |||||
| United States, Texas | |||||
| Central Texas Clinical Research | |||||
| Austin, Texas, United States, 78705 | |||||
| Hoffmann-La Roche |
| Trimeris |
More Information
| Study ID Numbers: | T20-206, 295B |
| First Received: | November 2, 1999 |
| Last Updated: | November 14, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002239 |
| Health Authority: | United States: Food and Drug Administration |
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