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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:
ClinicalTrials.gov Identifier:
NCT00488059
First Posted: June 19, 2007
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Trimeris
Information provided by:
Hoffmann-La Roche
Results First Submitted: November 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: enfuvirtide [Fuzeon]
Drug: Optimized background ARV
Drug: Integrase inhibitor

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Phase 1: ENF 90mg SC BID (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).

Baseline Measures
   Phase 1: ENF 90mg SC BID 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (10.30) 
Gender 
[Units: Participants]
 
Female   5 
Male   24 


  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   Virologic Response Over Time in Phase I of the Study   [ Time Frame: Weeks 4, 8 & 12 ]

4.  Secondary:   HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study   [ Time Frame: Baseline and Weeks 4, 8, 12 & LOCF ]

5.  Secondary:   Virologic Response Over Time in Phase II of the Study   [ Time Frame: Weeks II-4, 8, 12 & 16 ]

6.  Secondary:   CD4+ Lymphocyte Count Change From Baseline   [ Time Frame: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF ]

7.  Secondary:   Percentage of Patients With Ongoing Injection Site Reactions (ISRs)   [ Time Frame: Phase I and II ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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