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BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

This study has been completed.
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00326963
First received: May 16, 2006
Last updated: July 7, 2016
Last verified: July 2016
History of Changes
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Background ARVs
Drug: PI
Drug: enfuvirtide [Fuzeon]

  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
A total of 142 participants were enrolled in this study conducted from 6 March 2006 to 20 April 2007 at 33 centers to be investigated in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 142 participants were randomized, of which 140 received the study drug. A total of 2 randomized participants did not receive study drug.

Reporting Groups
  Description
Enfuvirtide+PI+ARV’s Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½” needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).

Participant Flow:   Overall Study
    Enfuvirtide+PI+ARV’s  
STARTED     140  
COMPLETED     107  
NOT COMPLETED     33  
Adverse Event                 2  
Injection site reaction                 1  
Death                 1  
Failure to return                 10  
Withdrawal by Subject                 10  
Refused treatment / did not cooperate                 5  
Violation of selection criteria at entry                 2  
Other protocol violation                 1  
Administrative / other                 1  



  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.
Baseline analysis was performed on all randomized participants including two participants who does not received study drug.

Reporting Groups
  Description
Enfuvirtide+PI+ARV’s Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.

Baseline Measures
    Enfuvirtide+PI+ARV’s  
Number of Participants  
[units: participants]
 		  142  
Age  
[units: years]
Mean (Standard Deviation) 		  46.2  (7.68)  
Gender  
[units: participants]
 		 
Female     20  
Male     122  



  Outcome Measures
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1.  Primary:   Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL   [ Time Frame: Week 24 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL   [ Time Frame: Week 24 ]
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3.  Secondary:   Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL   [ Time Frame: Week 4 and 12 ]
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4.  Secondary:   Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL   [ Time Frame: Week 4 and 12 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL   [ Time Frame: Weeks 4, 12, and 24 ]
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6.  Secondary:   Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL   [ Time Frame: Weeks 4, 12, and 24 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load   [ Time Frame: Baseline (Day 1), Weeks 4, 12, and 24 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)   [ Time Frame: Up to Week 28 ]
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9.  Secondary:   Change From Baseline in CD4+ Lymphocyte Count   [ Time Frame: Baseline (Day 1), Weeks 4, 12, and 24 ]
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10.  Secondary:   Number of Participants Meeting Virologic Failure Criteria   [ Time Frame: Weeks 12 and 24 ]
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11.  Secondary:   Percentage of Participants Meeting Virologic Failure Criteria   [ Time Frame: Weeks 12 and 24 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants Adhering to Enfuvirtide (ENF)   [ Time Frame: Weeks 4, 12, and 24 ]
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13.  Secondary:   Percentage of Participants Adhering to ENF   [ Time Frame: Weeks 4, 12, and 24 ]
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14.  Secondary:   Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event   [ Time Frame: Week 1 to Week 24 ]
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15.  Secondary:   Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event   [ Time Frame: Week 1 to Week 24 ]
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16.  Secondary:   Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.   [ Time Frame: Week 24 ]
  Show Outcome Measure 16

17.  Secondary:   Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events   [ Time Frame: Up to Week 24 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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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  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.


Results Point of Contact:  
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00326963     History of Changes
Other Study ID Numbers: ML19712
Study First Received: May 16, 2006
Results First Received: March 23, 2016
Last Updated: July 7, 2016
Health Authority: United States: Food and Drug Administration