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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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
  Hide Other Adverse Events

Time Frame Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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).
Phase II Arm A: Phase I Then 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).

In the randomized comparator phase 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

(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.

Phase II Arm B: Phase I Then ENF 180mg SC QD

(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).

In the randomized comparator phase 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

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


Other Adverse Events
    Phase I: ENF 90mg SC BID     Phase II Arm A: Phase I Then ENF 90mg SC BID     Phase II Arm B: Phase I Then ENF 180mg SC QD  
Total, other (not including serious) adverse events        
# participants affected / at risk     2/29     0/9     0/5  
Gastrointestinal disorders        
Diarrhoea * 1      
# participants affected / at risk     1/29 (3.45%)     0/9 (0.00%)     0/5 (0.00%)  
Skin and subcutaneous tissue disorders        
Rash morbilliform * 1      
# participants affected / at risk     1/29 (3.45%)     0/9 (0.00%)     0/5 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (11.1)



  Limitations and Caveats
  Hide 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.


  More Information