A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients (AMICI)
|HIV Infections||Drug: enfuvirtide [Fuzeon] Drug: Optimized background ARV Drug: Integrase inhibitor||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
- 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 ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488059
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|Study Director:||Clinical Trials||Hoffmann-La Roche|