A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients (AMICI)

This study has been terminated.
(This study was terminated early due to poor enrollment.)
Sponsor:
Collaborator:
Trimeris
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00488059
First received: June 18, 2007
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.


Condition Intervention Phase
HIV Infections
Drug: enfuvirtide [Fuzeon]
Drug: Optimized background ARV
Drug: Integrase inhibitor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study Evaluating the Antiviral Activity and Safety of Enfuvirtide (ENF) Once Daily (QD) or Twice Daily (BID) in Triple-class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care (SOC) Regimen That Includes Initiating Raltegravir Plus an Optimized Background (OB) Antiviral Regimen

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL [ Time Frame: Between Week I-4 and Week I-12 of Phase I of the study ] [ Designated as safety issue: No ]
    Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)

  • Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16 [ Time Frame: Week II-16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virologic Response Over Time in Phase I of the Study [ Time Frame: Weeks 4, 8 & 12 ] [ Designated as safety issue: No ]
    The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week are summarized below.

  • HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study [ Time Frame: Baseline and Weeks 4, 8, 12 & LOCF ] [ Designated as safety issue: No ]
    Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 & LOCF for ITT patients in Phase I of the study

  • Virologic Response Over Time in Phase II of the Study [ Time Frame: Weeks II-4, 8, 12 & 16 ] [ Designated as safety issue: No ]
    The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week.

  • CD4+ Lymphocyte Count Change From Baseline [ Time Frame: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF ] [ Designated as safety issue: No ]

    Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm.

    Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16.


  • Percentage of Patients With Ongoing Injection Site Reactions (ISRs) [ Time Frame: Phase I and II ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I
Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
Drug: enfuvirtide [Fuzeon]
90 mg SC twice daily
Drug: Optimized background ARV
As prescribed
Drug: Integrase inhibitor
As prescribed
Experimental: Phase II

In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of

(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.

Drug: Optimized background ARV
As prescribed
Drug: Integrase inhibitor
As prescribed
Drug: enfuvirtide [Fuzeon]
180 mg SC once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >=18 years of age
  • HIV-1 infection
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488059

  Hide Study Locations
Locations
United States, Alabama
Hobson City, Alabama, United States, 36201
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, California
Los Angeles, California, United States, 90028
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90069
Los Angeles, California, United States, 90027
Modesto, California, United States, 95350
Stanford, California, United States, 94305
United States, District of Columbia
Washington, District of Columbia, United States, 20009
United States, Florida
Fort Lauderdale, Florida, United States, 33334
Fort Lauderdale, Florida, United States, 33307
Fort Myers, Florida, United States, 39912
Miami, Florida, United States, 33133
Miami Beach, Florida, United States, 33139
North Palm Beach, Florida, United States, 33408
Orlando, Florida, United States, 32803
Plantation, Florida, United States, 33317
Port St Lucie, Florida, United States, 34952
Safety Harbor, Florida, United States, 36495
South Miami, Florida, United States, 33143
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30318
Macon, Georgia, United States, 31201
United States, Illinois
Chicago, Illinois, United States, 60657
United States, Maryland
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Boston, Massachusetts, United States, 02215-3318
United States, Missouri
Kansas City, Missouri, United States, 64111
St Louis, Missouri, United States, 63139
United States, New Jersey
Newark, New Jersey, United States, 07102
United States, New York
Briarcliff Manor, New York, United States, 10510
Bronx, New York, United States, 10467-2490
New York, New York, United States, 10003
Rochester, New York, United States, 14604
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18102-7017
Philadelphia, Pennsylvania, United States, 19107
Reading, Pennsylvania, United States, 19601
United States, Texas
Dallas, Texas, United States, 75246
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77098
United States, Virginia
Annandale, Virginia, United States, 22003
Puerto Rico
Ponce, Puerto Rico, 00717-1563
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Hoffmann-La Roche
Trimeris
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00488059     History of Changes
Other Study ID Numbers: ML20837
Study First Received: June 18, 2007
Results First Received: November 11, 2009
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Enfuvirtide
Integrase Inhibitors
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014