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
Results First Received: November 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: enfuvirtide [Fuzeon]
Drug: Optimized background ARV
Drug: Integrase inhibitor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Phase I of the study was a single group. In Phase II of the study, the remaining patients were randomized to either the enfuvirtide (90 mg) BID group or the enfuvirtide (180 mg) QD group.

Reporting Groups
  Description
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).
Phase II - Arm A Phase I then enfuvirtide 90 mg SC BID + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
Phase II - Arm B Phase I then enfuvirtide 180 mg SC QD (2 x 90-mg injections) + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)

Participant Flow for 3 periods

Period 1:   Phase I: ENF 90mg SC BID
    Phase I     Phase II - Arm A     Phase II - Arm B  
STARTED     29     0     0  
COMPLETED     14     0     0  
NOT COMPLETED     15     0     0  

Period 2:   Phase II Arm A:Phase I Then ENF 90mg BID
    Phase I     Phase II - Arm A     Phase II - Arm B  
STARTED     0     9     0  
COMPLETED     0     7     0  
NOT COMPLETED     0     2     0  

Period 3:   Phase II Arm B:Phase I Then ENF 180mg QD
    Phase I     Phase II - Arm A     Phase II - Arm B  
STARTED     0     0     5  
COMPLETED     0     0     1  
NOT COMPLETED     0     0     4  



  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.
No text entered.

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  
Number of Participants  
[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 ]
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Measure Type Primary
Measure Title Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Measure Description 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)
Time Frame Between Week I-4 and Week I-12 of Phase I of the study  
Safety Issue No  

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.
Intent-to-treat population

Reporting Groups
  Description
Phase I: 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).

Measured Values
    Phase I: ENF 90mg SC BID  
Number of Participants Analyzed  
[units: participants]
  29  
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL  
[units: participants]
 
Week 8     8  
Week 12     5  
Week 16     1  

No statistical analysis provided for Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL



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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590


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