A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients (AMICI)
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|ClinicalTrials.gov Identifier: NCT00488059|
Recruitment Status : Terminated (This study was terminated early due to poor enrollment.)
First Posted : June 19, 2007
Results First Posted : June 29, 2011
Last Update Posted : July 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: enfuvirtide [Fuzeon] Drug: Optimized background ARV Drug: Integrase inhibitor||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
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 dailyDrug: Optimized background ARV
As prescribedDrug: Integrase inhibitor
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 prescribedDrug: Integrase inhibitor
As prescribedDrug: enfuvirtide [Fuzeon]
180 mg SC once daily
- 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 ]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 ]
- Virologic Response Over Time in Phase I of the Study [ Time Frame: Weeks 4, 8 & 12 ]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 ]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 ]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 ]
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488059
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|Study Director:||Clinical Trials||Hoffmann-La Roche|