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

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

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
Overall Participants Analyzed  [Units: Participants]	142
Age  [Units: Years] Mean (Standard Deviation)	46.2  (7.68)
Gender  [Units: Participants]
Female	20
Male	122

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 ]

2.  Primary:

Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL   [ Time Frame: Week 24 ]

3.  Secondary:

Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL   [ Time Frame: Week 4 and 12 ]

4.  Secondary:

Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL   [ Time Frame: Week 4 and 12 ]

5.  Secondary:

Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL   [ Time Frame: Weeks 4, 12, and 24 ]

6.  Secondary:

Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL   [ Time Frame: Weeks 4, 12, and 24 ]

7.  Secondary:

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

8.  Secondary:

Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)   [ Time Frame: Up to Week 28 ]

9.  Secondary:

Change From Baseline in CD4+ Lymphocyte Count   [ Time Frame: Baseline (Day 1), Weeks 4, 12, and 24 ]

10.  Secondary:

Number of Participants Meeting Virologic Failure Criteria   [ Time Frame: Weeks 12 and 24 ]

11.  Secondary:

Percentage of Participants Meeting Virologic Failure Criteria   [ Time Frame: Weeks 12 and 24 ]

12.  Secondary:

Number of Participants Adhering to Enfuvirtide (ENF)   [ Time Frame: Weeks 4, 12, and 24 ]

13.  Secondary:

Percentage of Participants Adhering to ENF   [ Time Frame: Weeks 4, 12, and 24 ]

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 ]

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 ]

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 ]

17.  Secondary:

Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events   [ Time Frame: Up to Week 24 ]

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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