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

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ClinicalTrials.gov Identifier: NCT00326963
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Background ARVs
Drug: PI
Drug: enfuvirtide [Fuzeon]
Enrollment 142
Recruitment Details 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 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.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 140
Completed 107
Not Completed 33
Reason Not Completed
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
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 142
Hide Baseline Analysis Population Description
Baseline analysis was performed on all randomized participants including two participants who does not received study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants
46.2  (7.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
Female
20
  14.1%
Male
122
  85.9%
1.Primary Outcome
Title Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Hide Description Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results <50 copies/mL is reported.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: participants
Imputation by neighboring visit values; At Week 24 79
Without imputation by neighboring visit;At Week 24 78
2.Primary Outcome
Title Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Hide Description Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results <50 copies/mL is reported.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Percentage of Participants
Imputation by neighboring visit values; At Week 24
60.3 [1] 
(51.5 to NA)
Without imputation by neighboring visit;At Week 24
59.5 [1] 
(50.8 to NA)
[1]
We reported lower confidence limit from 1-sided 97.5% confidence interval which was constructed using the normal approximation to the binomial distribution therefore, upper limit is not required. Hence, presented as NA.
3.Secondary Outcome
Title Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Hide Description Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported.
Time Frame Week 4 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: participants
Imputation by neighboring visit values; At Week 4 28
Without imputation by neighboring visit; At Week 4 28
Imputation by neighboring visit values; At Week 12 64
Without imputation by neighboring visit;At Week 12 63
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Hide Description Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results <50 copies/mL is reported.
Time Frame Week 4 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Imputation by neighboring visit values; At Week 4
21.4
(14.0 to 28.8)
Without imputation by neighboring visit; At Week 4
21.4
(14.0 to 28.8)
Imputation by neighboring visit values; At Week 12
48.9
(39.9 to 57.8)
Without imputation by neighboring visit;At Week 12
48.1
(39.2 to 57.0)
5.Secondary Outcome
Title Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Hide Description Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.
Time Frame Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: participants
Imputation by neighboring visit values; At Week 4 74
Imputation by neighboring visit values; At Week 12 89
Imputation by neighboring visit values; At Week 24 95
Without imputation by neighboring visit;At Week 4 74
Without imputation by neighboring visit;At Week 12 88
Without imputation by neighboring visit;At Week 24 94
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Hide Description Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.
Time Frame Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Imputation by neighboring visit values; At Week 4
56.5
(47.6 to 65.4)
Imputation by neighboring visit values; At Week 12
67.9
(59.6 to 76.3)
Imputation by neighboring visit values; At Week 24
72.5
(64.5 to 80.5)
Without imputation by neighboring visit;At Week 4
56.5
(47.6 to 65.4)
Without imputation by neighboring visit;At Week 12
67.2
(58.8 to 75.6)
Without imputation by neighboring visit;At Week 24
71.8
(63.7 to 79.8)
7.Secondary Outcome
Title Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
Hide Description Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) – (plasma HIV-1 RNA count at baseline).
Time Frame Baseline (Day 1), Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 116
Mean (Standard Deviation)
Unit of Measure: copies/mL
At Week 4; n = 116 -2.22  (0.783)
At Week 12; n = 109 -2.51  (0.961)
At Week 24; n = 107 -2.61  (1.099)
8.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.
Time Frame Up to Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: participants
Number of participants with at least one AE 15
Number of participants with at least one SAE 13
9.Secondary Outcome
Title Change From Baseline in CD4+ Lymphocyte Count
Hide Description Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) – (CD4+ count at baseline).
Time Frame Baseline (Day 1), Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
At Week 4; n = 114 56  (93.6)
At Week 12; n = 109 83  (112.9)
At Week 24; n = 105 89  (103.4)
10.Secondary Outcome
Title Number of Participants Meeting Virologic Failure Criteria
Hide Description The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.
Time Frame Weeks 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: participants
Confirmed Failure; At Week 12 2
Confirmed Failure; At Week 24 10
Suspected Failure; At Week 12 19
Suspected Failure; At Week 24 45
11.Secondary Outcome
Title Percentage of Participants Meeting Virologic Failure Criteria
Hide Description The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.
Time Frame Weeks 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: Percentage of participants
Confirmed Failure; At Week 12 1.5
Confirmed Failure; At Week 24 7.6
Suspected Failure; At Week 12 14.5
Suspected Failure; At Week 24 34.4
12.Secondary Outcome
Title Number of Participants Adhering to Enfuvirtide (ENF)
Hide Description Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.
Time Frame Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population.The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: participants
100%; At Week 4; n = 125 108
≥95%; At Week 4; n = 125 108
≥90%; At Week 4; n = 125 108
≥85%; At Week 4; n = 125 119
100%; At Week 12; n = 113 98
≥95%; At Week 12; n = 113 98
≥90%; At Week 12; n = 113 98
≥85%; At Week 12; n = 113 106
100%; At Week 24; n = 93 79
≥95%; At Week 24; n = 93 79
≥90%; At Week 24; n = 93 79
≥85%; At Week 24; n = 93 87
13.Secondary Outcome
Title Percentage of Participants Adhering to ENF
Hide Description Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.
Time Frame Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: Percentage of Participants
100%; At Week 4; n = 125 86.4
≥95%; At Week 4; n = 125 86.4
≥90%; At Week 4; n = 125 86.4
≥85%; At Week 4; n = 125 95.2
100%; At Week 12; n = 113 86.7
≥95%; At Week 12; n = 113 86.7
≥90%; At Week 12; n = 113 86.7
≥85%; At Week 12; n = 113 93.8
100%; At Week 24; n = 93 84.9
≥95%; At Week 24; n = 93 84.9
≥90%; At Week 24; n = 93 84.9
≥85%; At Week 24; n = 93 93.5
14.Secondary Outcome
Title Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Hide Description Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.
Time Frame Week 1 to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: participants
0
15.Secondary Outcome
Title Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Hide Description Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.
Time Frame Week 1 to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: Percentage of participants
0
16.Secondary Outcome
Title Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Hide Description Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up. Maximum number of participants available at the particular time point were analysed and reported.
Arm/Group Title Enfuride+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Ongoing Pain/Discomfort, Grade 0; n= 110 73
Ongoing Pain/Discomfort, Grade 1; n= 110 24
Ongoing Pain/Discomfort, Grade 2; n= 110 11
Ongoing Pain/Discomfort, Grade 3; n= 110 1
Erythema, Grade 0; n= 110 68
Erythema, Grade 1; n= 110 23
Erythema, Grade 2; n= 110 12
Erythema, Grade 3; n= 110 5
Erythema, Grade 4; n= 110 1
Erythema, Grade 3 & 4; n= 110 6
Induration, Grade 0; n= 110 57
Induration, Grade 1; n= 110 12
Induration, Grade 2; n= 110 19
Induration, Grade 3; n= 110 13
Induration, Grade 4; n= 110 8
Induration, Grade 3 & 4; n= 110 21
Pruritus, Grade 0; n= 110 96
Pruritus, Grade 1; n= 110 13
Pruritus, Grade 2; n= 110 0
Pruritus, Grade 3; n= 110 0
Nodules and Cysts, Grade 0; n= 110 90
Nodules and Cysts, Grade 1; n= 110 8
Nodules and Cysts, Grade 2; n= 110 3
Nodules and Cysts, Grade 3; n= 110 8
Nodules and Cysts, Grade 4; n= 110 0
Nodules and Cysts, Grade 3 & 4; n= 110 8
Ecchymosis, Grade 0; n= 110 82
Ecchymosis, Grade 1; n= 110 13
Ecchymosis, Grade 2; n= 110 6
Ecchymosis, Grade 3; n= 110 6
Ecchymosis, Grade 4; n= 110 2
Ecchymosis, Grade 3 & 4; n= 110 8
17.Secondary Outcome
Title Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Hide Description The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade≥3 laboratory toxicities) were noted and presented.
Time Frame Up to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 137
Measure Type: Number
Unit of Measure: participants
Total participants with at least one AE 3
Upper Gastrointestinal haemorrhage 1
Sepsis 1
Rash 1
Time Frame Up to Week 28.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enfuvirtide+PI+ARV’s
Hide Arm/Group Description 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.
All-Cause Mortality
Enfuvirtide+PI+ARV’s
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enfuvirtide+PI+ARV’s
Affected / at Risk (%)
Total   13/137 (9.49%) 
Blood and lymphatic system disorders   
Anaemia  1  1/137 (0.73%) 
Gastrointestinal disorders   
Upper Gastrointestinal haemorrhage  1  1/137 (0.73%) 
Infections and infestations   
Cellulitis  1  2/137 (1.46%) 
Pneumonia  1  2/137 (1.46%) 
Sepsis  1  2/137 (1.46%) 
Pneumocystis jiroveci Pneumonia  1  1/137 (0.73%) 
Pneumonia primary atypical  1  1/137 (0.73%) 
Sinusitis  1  1/137 (0.73%) 
Investigations   
Neutrophil count decreased  1  1/137 (0.73%) 
Metabolism and nutrition disorders   
Metabolic acidosis  1  1/137 (0.73%) 
Musculoskeletal and connective tissue disorders   
Myopathy steroid  1  1/137 (0.73%) 
Renal and urinary disorders   
Renal failure  1  2/137 (1.46%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/137 (0.73%) 
Dyspnoea  1  1/137 (0.73%) 
Skin and subcutaneous tissue disorders   
Erythema nodosum  1  1/137 (0.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enfuvirtide+PI+ARV’s
Affected / at Risk (%)
Total   0/137 (0.00%) 
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00326963     History of Changes
Other Study ID Numbers: ML19712
First Submitted: May 16, 2006
First Posted: May 17, 2006
Results First Submitted: March 23, 2016
Results First Posted: August 16, 2016
Last Update Posted: August 16, 2016