Trial Outcomes & Findings for A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients (NCT NCT00488059)
NCT ID: NCT00488059
Last Updated: 2011-07-22
Results Overview
Virologic responders were defined as patients who had an initial HIV-1 RNA assessment \<= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Between Week I-4 and Week I-12 of Phase I of the study
Results posted on
2011-07-22
Participant Flow
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.
Participant milestones
| Measure |
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)
|
|---|---|---|---|
|
Phase I: ENF 90mg SC BID
STARTED
|
29
|
0
|
0
|
|
Phase I: ENF 90mg SC BID
COMPLETED
|
14
|
0
|
0
|
|
Phase I: ENF 90mg SC BID
NOT COMPLETED
|
15
|
0
|
0
|
|
Phase II Arm A:Phase I Then ENF 90mg BID
STARTED
|
0
|
9
|
0
|
|
Phase II Arm A:Phase I Then ENF 90mg BID
COMPLETED
|
0
|
7
|
0
|
|
Phase II Arm A:Phase I Then ENF 90mg BID
NOT COMPLETED
|
0
|
2
|
0
|
|
Phase II Arm B:Phase I Then ENF 180mg QD
STARTED
|
0
|
0
|
5
|
|
Phase II Arm B:Phase I Then ENF 180mg QD
COMPLETED
|
0
|
0
|
1
|
|
Phase II Arm B:Phase I Then ENF 180mg QD
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
Baseline characteristics by cohort
| Measure |
Phase 1: ENF 90mg SC BID
n=29 Participants
(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).
|
|---|---|
|
Age Continuous
|
45.4 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between Week I-4 and Week I-12 of Phase I of the studyPopulation: Intent-to-treat population
Virologic responders were defined as patients who had an initial HIV-1 RNA assessment \<= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)
Outcome measures
| Measure |
Phase I: ENF 90mg SC BID
n=29 Participants
(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 B: Phase I Then ENF 180mg SC QD
(Phase 1: ENF 90 mg 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 B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
|
Phase II - Arm B
Phase I then ENF 180 mg SC QD
|
|---|---|---|---|
|
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Week 8
|
8 participants
|
—
|
—
|
|
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Week 12
|
5 participants
|
—
|
—
|
|
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Week 16
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week II-16Population: Intent-to-treat population
Outcome measures
| Measure |
Phase I: ENF 90mg SC BID
n=9 Participants
(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 B: Phase I Then ENF 180mg SC QD
n=5 Participants
(Phase 1: ENF 90 mg 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 B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
|
Phase II - Arm B
Phase I then ENF 180 mg SC QD
|
|---|---|---|---|
|
Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16
|
5 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8 & 12Population: Intent-to-treat population
The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week are summarized below.
Outcome measures
| Measure |
Phase I: ENF 90mg SC BID
n=29 Participants
(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 B: Phase I Then ENF 180mg SC QD
(Phase 1: ENF 90 mg 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 B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
|
Phase II - Arm B
Phase I then ENF 180 mg SC QD
|
|---|---|---|---|
|
Virologic Response Over Time in Phase I of the Study
Week 4 (<= 50 copies/mL)
|
11 participants
|
—
|
—
|
|
Virologic Response Over Time in Phase I of the Study
Week 4 (< 400 copies/mL)
|
22 participants
|
—
|
—
|
|
Virologic Response Over Time in Phase I of the Study
Week 8 (<= 50 copies/mL)
|
14 participants
|
—
|
—
|
|
Virologic Response Over Time in Phase I of the Study
Week 8 (< 400 copies/mL)
|
22 participants
|
—
|
—
|
|
Virologic Response Over Time in Phase I of the Study
Week 12 (<= 50 copies/mL)
|
14 participants
|
—
|
—
|
|
Virologic Response Over Time in Phase I of the Study
Week 12 (< 400 copies/mL)
|
19 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12 & LOCFPopulation: Intent-to-treat population. Last Observation Carried Forward (LOCF) includes non-missing data values from the last post-baseline visit for each participant which was carried forward to impute missing data values.
Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 \& LOCF for ITT patients in Phase I of the study
Outcome measures
| Measure |
Phase I: ENF 90mg SC BID
n=29 Participants
(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 B: Phase I Then ENF 180mg SC QD
(Phase 1: ENF 90 mg 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 B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
|
Phase II - Arm B
Phase I then ENF 180 mg SC QD
|
|---|---|---|---|
|
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
change at Week 16 (n=10)
|
2.3 log10 copies/mL
Standard Deviation 0.90
|
—
|
—
|
|
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
Baseline (N=29)
|
4.4 log10 copies/mL
Standard Deviation 0.87
|
—
|
—
|
|
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
change at Week 4 (n=27)
|
2.1 log10 copies/mL
Standard Deviation 0.46
|
—
|
—
|
|
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
change at Week 8 (n=24)
|
2.0 log10 copies/mL
Standard Deviation 0.81
|
—
|
—
|
|
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
change at Week 12 (n=14)
|
2.4 log10 copies/mL
Standard Deviation 1.09
|
—
|
—
|
|
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
change at LOCF (n=27)
|
1.9 log10 copies/mL
Standard Deviation 0.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks II-4, 8, 12 & 16Population: intent-to-treat population
The number of intent-to-treat (ITT) participants with HIV-1 RNA \<= 50 copies/mL and HIV-1 RNA \< 400 copies/mL by study week.
Outcome measures
| Measure |
Phase I: ENF 90mg SC BID
n=9 Participants
(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 B: Phase I Then ENF 180mg SC QD
n=5 Participants
(Phase 1: ENF 90 mg 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 B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
|
Phase II - Arm B
Phase I then ENF 180 mg SC QD
|
|---|---|---|---|
|
Virologic Response Over Time in Phase II of the Study
Week 4 (<= 50 copies/mL)
|
5 participants
|
4 participants
|
—
|
|
Virologic Response Over Time in Phase II of the Study
Week 4 (< 400 copies/mL)
|
6 participants
|
4 participants
|
—
|
|
Virologic Response Over Time in Phase II of the Study
Week 8 (<= 50 copies/mL)
|
6 participants
|
4 participants
|
—
|
|
Virologic Response Over Time in Phase II of the Study
Week 8 (< 400 copies/mL)
|
7 participants
|
4 participants
|
—
|
|
Virologic Response Over Time in Phase II of the Study
Week 12 (<= 50 copies/mL)
|
6 participants
|
4 participants
|
—
|
|
Virologic Response Over Time in Phase II of the Study
Week 12 (< 400 copies/mL)
|
7 participants
|
4 participants
|
—
|
|
Virologic Response Over Time in Phase II of the Study
Week 16 (<= 50 copies/mL)
|
5 participants
|
3 participants
|
—
|
|
Virologic Response Over Time in Phase II of the Study
Week 16 (< 400 copies/mL)
|
6 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCFPopulation: Intent-to-treat
Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm. Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16.
Outcome measures
| Measure |
Phase I: ENF 90mg SC BID
n=9 Participants
(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 B: Phase I Then ENF 180mg SC QD
n=5 Participants
(Phase 1: ENF 90 mg 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 B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
|
Phase II - Arm B
Phase I then ENF 180 mg SC QD
|
|---|---|---|---|
|
CD4+ Lymphocyte Count Change From Baseline
Phase I baseline to Week 1 of Phase II (n=8,5)
|
22 cells/mm3
Interval -39.0 to 139.0
|
118.0 cells/mm3
Interval 26.0 to 239.0
|
—
|
|
CD4+ Lymphocyte Count Change From Baseline
Phase I baseline to Week 12 of Phase II (n=7,4)
|
83.0 cells/mm3
Interval 3.0 to 199.0
|
174.5 cells/mm3
Interval -14.0 to 301.0
|
—
|
|
CD4+ Lymphocyte Count Change From Baseline
Phase I baseline to Week 16 of Phase II (n=6,4)
|
61.0 cells/mm3
Interval 0.0 to 104.0
|
179.0 cells/mm3
Interval 18.0 to 225.0
|
—
|
SECONDARY outcome
Timeframe: Phase I and IIOutcome measures
| Measure |
Phase I: ENF 90mg SC BID
n=29 Participants
(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 B: Phase I Then ENF 180mg SC QD
n=9 Participants
(Phase 1: ENF 90 mg 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 B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
|
Phase II - Arm B
n=5 Participants
Phase I then ENF 180 mg SC QD
|
|---|---|---|---|
|
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Any type
|
92 Percentage of patients
|
100 Percentage of patients
|
100 Percentage of patients
|
|
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Pain/discomfort
|
52 Percentage of patients
|
42.9 Percentage of patients
|
60 Percentage of patients
|
|
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Erythema
|
80 Percentage of patients
|
71.4 Percentage of patients
|
100 Percentage of patients
|
|
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Induration
|
80 Percentage of patients
|
100 Percentage of patients
|
100 Percentage of patients
|
|
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Pruritus
|
44 Percentage of patients
|
28.6 Percentage of patients
|
20 Percentage of patients
|
|
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Nodules
|
56 Percentage of patients
|
57.1 Percentage of patients
|
80 Percentage of patients
|
|
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Ecchymosis
|
40 Percentage of patients
|
14.3 Percentage of patients
|
20 Percentage of patients
|
Adverse Events
Phase I: ENF 90mg SC BID
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase II Arm A: Phase I Then ENF 90mg SC BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase II Arm B: Phase I Then ENF 180mg SC QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: ENF 90mg SC BID
n=29 participants at risk
(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
n=9 participants at risk
(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
n=5 participants at risk
(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.
|
|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
Nervous system disorders
Transient ischaemic attack
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
General disorders
Death
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
Infections and infestations
Cytomegalovirus viraemia
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
Psychiatric disorders
Suicidal ideation
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
Other adverse events
| Measure |
Phase I: ENF 90mg SC BID
n=29 participants at risk
(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
n=9 participants at risk
(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
n=5 participants at risk
(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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
3.4%
1/29 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/9 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
0.00%
0/5 • Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800-821-8590
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