Trial Outcomes & Findings for BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1. (NCT NCT00326963)
NCT ID: NCT00326963
Last Updated: 2016-08-16
Results Overview
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.
COMPLETED
PHASE4
142 participants
Week 24
2016-08-16
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
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|---|---|
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Overall Study
STARTED
|
140
|
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Overall Study
COMPLETED
|
107
|
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Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
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).
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|---|---|
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Overall Study
Adverse Event
|
2
|
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Overall Study
Injection site reaction
|
1
|
|
Overall Study
Death
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1
|
|
Overall Study
Failure to return
|
10
|
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Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Refused treatment / did not cooperate
|
5
|
|
Overall Study
Violation of selection criteria at entry
|
2
|
|
Overall Study
Other protocol violation
|
1
|
|
Overall Study
Administrative / other
|
1
|
Baseline Characteristics
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
Baseline characteristics by cohort
| Measure |
Enfuvirtide+PI+ARV's
n=142 Participants
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.
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|---|---|
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Age, Continuous
|
46.2 years
STANDARD_DEVIATION 7.68 • n=5 Participants
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Sex: Female, Male
Female
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20 Participants
n=5 Participants
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Sex: Female, Male
Male
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122 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Imputation by neighboring visit values; At Week 24
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79 participants
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Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Without imputation by neighboring visit;At Week 24
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78 participants
|
PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Imputation by neighboring visit values; At Week 24
|
60.3 Percentage of Participants
Interval 51.5 to
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.
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Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Without imputation by neighboring visit;At Week 24
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59.5 Percentage of Participants
Interval 50.8 to
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.
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SECONDARY outcome
Timeframe: Week 4 and 12Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Imputation by neighboring visit values; At Week 12
|
64 participants
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|
Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Without imputation by neighboring visit;At Week 12
|
63 participants
|
|
Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Imputation by neighboring visit values; At Week 4
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28 participants
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Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Without imputation by neighboring visit; At Week 4
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28 participants
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SECONDARY outcome
Timeframe: Week 4 and 12Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Imputation by neighboring visit values; At Week 4
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21.4 Percentage of Participants
Interval 14.0 to 28.8
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|
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Without imputation by neighboring visit; At Week 4
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21.4 Percentage of Participants
Interval 14.0 to 28.8
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Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Imputation by neighboring visit values; At Week 12
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48.9 Percentage of Participants
Interval 39.9 to 57.8
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Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Without imputation by neighboring visit;At Week 12
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48.1 Percentage of Participants
Interval 39.2 to 57.0
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SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Without imputation by neighboring visit;At Week 24
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94 participants
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Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Imputation by neighboring visit values; At Week 4
|
74 participants
|
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Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Imputation by neighboring visit values; At Week 12
|
89 participants
|
|
Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Imputation by neighboring visit values; At Week 24
|
95 participants
|
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Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Without imputation by neighboring visit;At Week 4
|
74 participants
|
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Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Without imputation by neighboring visit;At Week 12
|
88 participants
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SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Imputation by neighboring visit values; At Week 4
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56.5 Percentage of participants
Interval 47.6 to 65.4
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|
Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Imputation by neighboring visit values; At Week 24
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72.5 Percentage of participants
Interval 64.5 to 80.5
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Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Without imputation by neighboring visit;At Week 4
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56.5 Percentage of participants
Interval 47.6 to 65.4
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|
Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Without imputation by neighboring visit;At Week 12
|
67.2 Percentage of participants
Interval 58.8 to 75.6
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|
Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Without imputation by neighboring visit;At Week 24
|
71.8 Percentage of participants
Interval 63.7 to 79.8
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|
Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Imputation by neighboring visit values; At Week 12
|
67.9 Percentage of participants
Interval 59.6 to 76.3
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SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4, 12, and 24Population: 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.
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).
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=116 Participants
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.
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|---|---|
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Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
At Week 4; n = 116
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-2.22 copies/mL
Standard Deviation 0.783
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Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
At Week 12; n = 109
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-2.51 copies/mL
Standard Deviation 0.961
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|
Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
At Week 24; n = 107
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-2.61 copies/mL
Standard Deviation 1.099
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SECONDARY outcome
Timeframe: Up to Week 28Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=137 Participants
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.
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|---|---|
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Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Number of participants with at least one AE
|
15 participants
|
|
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Number of participants with at least one SAE
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4, 12, and 24Population: 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.
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).
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=114 Participants
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.
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|---|---|
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Change From Baseline in CD4+ Lymphocyte Count
At Week 4; n = 114
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56 cells/mm^3
Standard Deviation 93.6
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|
Change From Baseline in CD4+ Lymphocyte Count
At Week 12; n = 109
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83 cells/mm^3
Standard Deviation 112.9
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Change From Baseline in CD4+ Lymphocyte Count
At Week 24; n = 105
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89 cells/mm^3
Standard Deviation 103.4
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Number of Participants Meeting Virologic Failure Criteria
Confirmed Failure; At Week 12
|
2 participants
|
|
Number of Participants Meeting Virologic Failure Criteria
Suspected Failure; At Week 24
|
45 participants
|
|
Number of Participants Meeting Virologic Failure Criteria
Confirmed Failure; At Week 24
|
10 participants
|
|
Number of Participants Meeting Virologic Failure Criteria
Suspected Failure; At Week 12
|
19 participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=131 Participants
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.
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|---|---|
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Percentage of Participants Meeting Virologic Failure Criteria
Confirmed Failure; At Week 24
|
7.6 Percentage of participants
|
|
Percentage of Participants Meeting Virologic Failure Criteria
Suspected Failure; At Week 24
|
34.4 Percentage of participants
|
|
Percentage of Participants Meeting Virologic Failure Criteria
Confirmed Failure; At Week 12
|
1.5 Percentage of participants
|
|
Percentage of Participants Meeting Virologic Failure Criteria
Suspected Failure; At Week 12
|
14.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=125 Participants
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.
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|---|---|
|
Number of Participants Adhering to Enfuvirtide (ENF)
100%; At Week 12; n = 113
|
98 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥95%; At Week 12; n = 113
|
98 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥85%; At Week 12; n = 113
|
106 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
100%; At Week 24; n = 93
|
79 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥85%; At Week 24; n = 93
|
87 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
100%; At Week 4; n = 125
|
108 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥95%; At Week 4; n = 125
|
108 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥90%; At Week 4; n = 125
|
108 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥85%; At Week 4; n = 125
|
119 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥90%; At Week 12; n = 113
|
98 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥95%; At Week 24; n = 93
|
79 participants
|
|
Number of Participants Adhering to Enfuvirtide (ENF)
≥90%; At Week 24; n = 93
|
79 participants
|
SECONDARY outcome
Timeframe: Weeks 4, 12, and 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=125 Participants
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.
|
|---|---|
|
Percentage of Participants Adhering to ENF
100%; At Week 4; n = 125
|
86.4 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
100%; At Week 12; n = 113
|
86.7 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥95%; At Week 12; n = 113
|
86.7 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥90%; At Week 12; n = 113
|
86.7 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
100%; At Week 24; n = 93
|
84.9 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥95%; At Week 24; n = 93
|
84.9 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥90%; At Week 24; n = 93
|
84.9 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥95%; At Week 4; n = 125
|
86.4 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥90%; At Week 4; n = 125
|
86.4 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥85%; At Week 4; n = 125
|
95.2 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥85%; At Week 12; n = 113
|
93.8 Percentage of Participants
|
|
Percentage of Participants Adhering to ENF
≥85%; At Week 24; n = 93
|
93.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=137 Participants
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.
|
|---|---|
|
Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
|
0 participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=137 Participants
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.
|
|---|---|
|
Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=110 Participants
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.
|
|---|---|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Erythema, Grade 2; n= 110
|
12 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Erythema, Grade 3; n= 110
|
5 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Induration, Grade 4; n= 110
|
8 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Pruritus, Grade 2; n= 110
|
0 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Nodules and Cysts, Grade 2; n= 110
|
3 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Nodules and Cysts, Grade 3 & 4; n= 110
|
8 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ecchymosis, Grade 0; n= 110
|
82 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ongoing Pain/Discomfort, Grade 0; n= 110
|
73 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ongoing Pain/Discomfort, Grade 1; n= 110
|
24 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ongoing Pain/Discomfort, Grade 2; n= 110
|
11 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ongoing Pain/Discomfort, Grade 3; n= 110
|
1 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Erythema, Grade 0; n= 110
|
68 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Erythema, Grade 1; n= 110
|
23 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Erythema, Grade 4; n= 110
|
1 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Erythema, Grade 3 & 4; n= 110
|
6 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Induration, Grade 0; n= 110
|
57 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Induration, Grade 1; n= 110
|
12 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Induration, Grade 2; n= 110
|
19 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Induration, Grade 3; n= 110
|
13 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Induration, Grade 3 & 4; n= 110
|
21 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Pruritus, Grade 0; n= 110
|
96 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Pruritus, Grade 1; n= 110
|
13 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Pruritus, Grade 3; n= 110
|
0 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Nodules and Cysts, Grade 0; n= 110
|
90 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Nodules and Cysts, Grade 1; n= 110
|
8 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Nodules and Cysts, Grade 3; n= 110
|
8 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Nodules and Cysts, Grade 4; n= 110
|
0 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ecchymosis, Grade 1; n= 110
|
13 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ecchymosis, Grade 2; n= 110
|
6 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ecchymosis, Grade 3; n= 110
|
6 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ecchymosis, Grade 4; n= 110
|
2 participants
|
|
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Ecchymosis, Grade 3 & 4; n= 110
|
8 participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: 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.
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.
Outcome measures
| Measure |
Enfuvirtide+PI+ARV's
n=137 Participants
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.
|
|---|---|
|
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Sepsis
|
1 participants
|
|
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Total participants with at least one AE
|
3 participants
|
|
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Upper Gastrointestinal haemorrhage
|
1 participants
|
|
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Rash
|
1 participants
|
Adverse Events
Enfuvirtide+PI+ARV's
Serious adverse events
| Measure |
Enfuvirtide+PI+ARV's
n=137 participants at risk
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.
|
|---|---|
|
Infections and infestations
Cellulitis
|
1.5%
2/137 • Up to Week 28.
|
|
Infections and infestations
Pneumonia
|
1.5%
2/137 • Up to Week 28.
|
|
Infections and infestations
Sepsis
|
1.5%
2/137 • Up to Week 28.
|
|
Infections and infestations
Pneumocystis jiroveci Pneumonia
|
0.73%
1/137 • Up to Week 28.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.73%
1/137 • Up to Week 28.
|
|
Infections and infestations
Sinusitis
|
0.73%
1/137 • Up to Week 28.
|
|
Renal and urinary disorders
Renal failure
|
1.5%
2/137 • Up to Week 28.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.73%
1/137 • Up to Week 28.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.73%
1/137 • Up to Week 28.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.73%
1/137 • Up to Week 28.
|
|
Gastrointestinal disorders
Upper Gastrointestinal haemorrhage
|
0.73%
1/137 • Up to Week 28.
|
|
Investigations
Neutrophil count decreased
|
0.73%
1/137 • Up to Week 28.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.73%
1/137 • Up to Week 28.
|
|
Musculoskeletal and connective tissue disorders
Myopathy steroid
|
0.73%
1/137 • Up to Week 28.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.73%
1/137 • Up to Week 28.
|
Other adverse events
Adverse event data not reported
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER