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New Trial to Study Investigational Integrase Inhibitor in Combination with FUZEON(R) Once-Daily Dosing Strategy for Triple HIV Drug Class Experienced
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July 17, 2007: 12:00 PM EST
NUTLEY, N.J. and MORRISVILLE, N.C., July 17 /PRNewswire-FirstCall/ -- Roche and Trimeris, Inc. today announced that patient dosing has begun in a new trial designed to evalute the efficacy and safety of FUZEON(R) (enfuvirtide) in combination with an investigational integrase inhibitor. The trial will also determine whether a novel, simplified FUZEON dosing strategy -- switching from twice-daily dosing to once-daily dosing -- can effectively maintain an undetectable viral load. This study, known as AMICI, is open to patients who are enrolling in an Expanded Access Program (EAP) for an investigational integrase inhibitor. AMICI is also open to additional integrase inhibitor EAP sites interested in becoming an AMICI trial site. FUZEON, co-developed by Roche and Trimeris , is the first and only fusion inhibitor available for the treatment of HIV.
"As new anti-HIV drugs enter the treatment landscape, it is important to conduct studies that provide detailed guidance to clinicians on how to use these agents with drugs, such as FUZEON, that are already in wide use in treatment-experienced patients. This trial is designed to shed light on several key questions," said Calvin J. Cohen, M.D., Research Director, Community Research Initiative of New England. "In addition to providing new data on the combination of FUZEON and an integrase inhibitor in a significant patient cohort, AMICI will provide insight on whether it is possible to simplify dosing of FUZEON to once-daily after undetectable HIV has been achieved. If shown to be a viable option, simplified dosing of FUZEON would be a welcome advance."
More About AMICI (Roche Protocol Number ML20837)
The study, being conducted at centers in the U.S., has a target enrollment of at least 238 HIV-infected, three-class treatment-experienced adults who have not previously been treated with FUZEON or an integrase inhibitor; whose HIV levels are greater than 1000 copies per mL of blood; and who have at least one fully active antiretroviral agent (in addition to FUZEON and the integrase inhibitor) for inclusion in their treatment regimen. The primary endpoint of AMICI is to evaluate the efficacy of this regimen, as measured by proportion of patients with undetectable HIV (less than 50 copies per mL of blood) by week 12. A second primary endpoint will determine whether FUZEON 180mg once daily is as effective as FUZEON 90mg twice daily in maintaining viral suppression for an additional 24 weeks in patients who achieve undetectable HIV by week 12. Those patients who achieve undetectable HIV by week 12 will be randomized to continue receiving 90 mg FUZEON twice-daily or to switch to 180 mg FUZEON (two injections) once-daily.
Additional details about the trial are available at http://www.roche-trials.com or http://clinicaltrials.gov/ct/show/NCT00488059?order=4.
http://clinicaltrials.gov
AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients.
This study is not yet open for patient recruitment.
Official Title: An Open Label Study Evaluating the Antiviral Activity and Safety of Fuzeon in Triple-Class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care Regimen Which Includes Initiating an Integrase Inhibitor in an Expanded Access Program Plus Optimized Background
Purpose
This study will evaluate the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus optimized background in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study, eligible patients will receive Fuzeon 90mg sc b.i.d. until confirmation of response (min/max = 8/16 weeks).In the second, randomised comparator phase of the study, responders will be randomized to receive Fuzeon either 90mg sc b.i.d. or 180mg qd for a further 24 weeks. Non-responders and virological failures will be terminated from the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Primary Outcome Measures:
* Number and percentage of patients with HIV RNA <50 copies/mL at week 12, and at week 38.
Secondary Outcome Measures:
* Efficacy: At multiple time points : mean change in HIV RNA and CD4 from baseline; no. and % of patients with HIV RNA <=50 copies/mL,and <400 copies/mL; no. & % of patients with >=1 log decline in HIV RNA from baseline. Safety:SAEs, ISRs, lab parameters.
Study start: June 2007
Inclusion Criteria:
* adult patients, >=18 years of age; HIV+
* triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive;
* GSS>=3; nucleosides excluded.
Exclusion Criteria:
* adverse clinical or laboratory experience >ACTG Grade 4;
* untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen;
* malignancy requiring chemotherapy or radiotherapy.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00488059
Please reference Study ID Number: RLI_ML20837 973-235-5000
or 800-526-6367 (FOR US ONLY)
United States, Alabama
HOBSON CITY, Alabama, 36201, United States
United States, Arizona
PHOENIX, Arizona, 85006, United States
United States, California
LOS ANGELES, California, 90028, United States
LOS ANGELES, California, 90069, United States
STANFORD, California, 94305, United States
BERKELEY, California, 94705, United States
LOS ANGELES, California, 90027, United States
United States, District of Columbia
WASHINGTON, District of Columbia, 20009, United States
United States, Florida
ORLANDO, Florida, 32803, United States
FORT LAUDERDALE, Florida, 33334, United States
SOUTH MIAMI, Florida, 33143, United States
PORT ST LUCIE, Florida, 34952, United States
FORT LAUDERDALE, Florida, 33307, United States
SAFETY HARBOR, Florida, 36495, United States
TAMPA, Florida, 33614, United States
United States, Georgia
ATLANTA, Georgia, 30309, United States
ATLANTA, Georgia, 30318, United States
MACON, Georgia, 31201, United States
United States, Idaho
BOISE, Idaho, 83704, United States
United States, Maryland
SILVER SPRING, Maryland, 20910, United States
United States, Massachusetts
BOSTON, Massachusetts, 02215-3318, United States
United States, New Jersey
NEWARK, New Jersey, 07102, United States
ENGLEWOOD, New Jersey, 07631, United States
United States, New York
ROCHESTER, New York, 14604, United States
NEW YORK, New York, 10003, United States
BRONX, New York, 10467-2490, United States
NEW YORK, New York, 10016, United States
United States, Pennsylvania
PHILADELPHIA, Pennsylvania, 19107, United States
United States, Tennessee
HERMITAGE, Tennessee, 37076, United States
United States, Texas
DALLAS, Texas, 75246, United States
HOUSTON, Texas, 77098, United States
United States, Virginia
ANNANDALE, Virginia, 22003, United States
NORFOLK, Virginia, 23507, United States
Puerto Rico
SANTURCE, 00909, Puerto Rico
PONCE, 00717-1563, Puerto Rico
Facts About FUZEON
Administered via one 90 mg injection twice-daily, FUZEON is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, FUZEON works outside the CD4 cell, blocking HIV from entering the cell. For this reason, FUZEON is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to FUZEON. FUZEON was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.
FUZEON is indicated for use in combination with other antiretroviral agents for the treatment of HIV in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with FUZEON. ISRs occurred in 98% of patients studied and 4% discontinued FUZEON due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities.
Pneumonia: An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. Patients with HIV infection should be carefully monitored for signs and symptoms of pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.
Hypersensitivity Reactions: Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome.
Administration with Biojector(R)2000: Nerve pain (neuralgia and/or parethesia) lasting up to six months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with the use of the Biojector 2000 needle-free device for administration of FUZEON. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.
Other Adverse Events: The events most frequently reported in patients receiving FUZEON plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a FUZEON-based regimen compared to those receiving an optimized background regimen without FUZEON when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based regimens vs. 73 per 100 patient-years in patients who did not receive FUZEON), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).
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