AMICI: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00488059
• Collaborator: Trimeris (Industry)
• Enrollment: 29
• Locations: 43
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV; Drug: Integrase inhibitor; Drug: enfuvirtide [Fuzeon]	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label Study Evaluating the Antiviral Activity and Safety of Enfuvirtide (ENF) Once Daily (QD) or Twice Daily (BID) in Triple-class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care (SOC) Regimen That Includes Initiating Raltegravir Plus an Optimized Background (OB) Antiviral Regimen
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: enfuvirtide [Fuzeon]; 90 mg SC twice daily; Drug: Optimized background ARV; As prescribed; Drug: Integrase inhibitor; As prescribed
Experimental: Phase II In the randomized comparator 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 1 of 2 treatment arms of (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 or (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.	Drug: Optimized background ARV; As prescribed; Drug: Integrase inhibitor; As prescribed; Drug: enfuvirtide [Fuzeon]; 180 mg SC once daily

Outcome Measures

Primary Outcome Measures

1. Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL [Between Week I-4 and Week I-12 of Phase I of the study]

   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)

2. Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16 [Week II-16]

Secondary Outcome Measures

1. Virologic Response Over Time in Phase I of the Study [Weeks 4, 8 & 12]

   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.

2. HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study [Baseline and Weeks 4, 8, 12 & LOCF]

   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

3. Virologic Response Over Time in Phase II of the Study [Weeks II-4, 8, 12 & 16]

   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.

4. CD4+ Lymphocyte Count Change From Baseline [Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF]

   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.

5. Percentage of Patients With Ongoing Injection Site Reactions (ISRs) [Phase I and II]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients, >=18 years of age

• HIV-1 infection

• Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive

• GSS >= 3 ; nucleosides excluded

Exclusion Criteria:

• Adverse clinical or laboratory experience >ACTG Grade 4

• Untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen

• Malignancy requiring chemotherapy or radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hobson City	Alabama	United States	36201
2		Phoenix	Arizona	United States	85006
3		Los Angeles	California	United States	90027
4		Los Angeles	California	United States	90028
5		Los Angeles	California	United States	90036
6		Los Angeles	California	United States	90069
7		Modesto	California	United States	95350
8		Stanford	California	United States	94305
9		Washington	District of Columbia	United States	20009
10		Fort Lauderdale	Florida	United States	33307
11		Fort Lauderdale	Florida	United States	33334
12		Fort Myers	Florida	United States	39912
13		Miami Beach	Florida	United States	33139
14		Miami	Florida	United States	33133
15		North Palm Beach	Florida	United States	33408
16		Orlando	Florida	United States	32803
17		Plantation	Florida	United States	33317
18		Port St Lucie	Florida	United States	34952
19		Safety Harbor	Florida	United States	36495
20		South Miami	Florida	United States	33143
21		Tampa	Florida	United States	33614
22		Atlanta	Georgia	United States	30309
23		Atlanta	Georgia	United States	30318
24		Macon	Georgia	United States	31201
25		Chicago	Illinois	United States	60657
26		Silver Spring	Maryland	United States	20910
27		Boston	Massachusetts	United States	02215-3318
28		Kansas City	Missouri	United States	64111
29		St Louis	Missouri	United States	63139
30		Newark	New Jersey	United States	07102
31		Briarcliff Manor	New York	United States	10510
32		Bronx	New York	United States	10467-2490
33		New York	New York	United States	10003
34		Rochester	New York	United States	14604
35		Allentown	Pennsylvania	United States	18102-7017
36		Philadelphia	Pennsylvania	United States	19107
37		Reading	Pennsylvania	United States	19601
38		Dallas	Texas	United States	75246
39		Fort Worth	Texas	United States	76104
40		Houston	Texas	United States	77098
41		Annandale	Virginia	United States	22003
42		Ponce		Puerto Rico	00717-1563
43		Santurce		Puerto Rico	00909

Sponsors and Collaborators

• Hoffmann-La Roche
• Trimeris

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Study Report Synopsis

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00488059
• Other Study ID Numbers: ML20837
• First Posted: Jun 19, 2007
• Last Update Posted: Jul 22, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Treatment Experienced
• Additional relevant MeSH terms: HIV Infections; Enfuvirtide; HIV Integrase Inhibitors; Integrase Inhibitors

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Phase I	Phase II - Arm A	Phase II - Arm B
Arm/Group Description	(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 I then enfuvirtide 90 mg SC BID + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)	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)
Period Title: Phase I: ENF 90mg SC BID
STARTED	29	0	0
COMPLETED	14	0	0
NOT COMPLETED	15	0	0
Period Title: Phase I: ENF 90mg SC BID
STARTED	0	9	0
COMPLETED	0	7	0
NOT COMPLETED	0	2	0
Period Title: Phase I: ENF 90mg SC BID
STARTED	0	0	5
COMPLETED	0	0	1
NOT COMPLETED	0	0	4

Baseline Characteristics

Arm/Group Title	Phase 1: ENF 90mg SC BID
Arm/Group Description	(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).
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.4 (10.30)
Sex: Female, Male (Count of Participants)
Female	5 17.2%
Male	24 82.8%

Outcome Measures

1. Primary Outcome

Title	Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Description	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)
Time Frame	Between Week I-4 and Week I-12 of Phase I of the study

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Phase I: ENF 90mg SC BID
Arm/Group Description	(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).
Measure Participants	29
Week 8	8 27.6%
Week 12	5 17.2%
Week 16	1 3.4%

2. Secondary Outcome

Title	Virologic Response Over Time in Phase I of the Study
Description	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.
Time Frame	Weeks 4, 8 & 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Phase I: ENF 90mg SC BID
Arm/Group Description	(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).
Measure Participants	29
Week 4 (<= 50 copies/mL)	11 37.9%
Week 4 (< 400 copies/mL)	22 75.9%
Week 8 (<= 50 copies/mL)	14 48.3%
Week 8 (< 400 copies/mL)	22 75.9%
Week 12 (<= 50 copies/mL)	14 48.3%
Week 12 (< 400 copies/mL)	19 65.5%

3. Primary Outcome

Title	Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16
Time Frame	Week II-16

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Phase II Arm A: Phase I Then ENF 90 mg SC BID	Phase II Arm B: Phase I Then ENF 180mg SC QD
Arm/Group Description	(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 A: Phase I+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 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.
Measure Participants	9	5
Number [participants]	5 17.2%	3 NaN

4. Secondary Outcome

Title	HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
Description	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
Time Frame	Baseline and Weeks 4, 8, 12 & LOCF

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Phase I: ENF 90mg SC BID
Arm/Group Description	(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).
Measure Participants	29
Baseline (N=29)	4.4 (0.87)
change at Week 4 (n=27)	2.1 (0.46)
change at Week 8 (n=24)	2.0 (0.81)
change at Week 12 (n=14)	2.4 (1.09)
change at Week 16 (n=10)	2.3 (0.90)
change at LOCF (n=27)	1.9 (0.61)

5. Secondary Outcome

Title	Virologic Response Over Time in Phase II of the Study
Description	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.
Time Frame	Weeks II-4, 8, 12 & 16

Outcome Measure Data

Analysis Population Description

intent-to-treat population

Arm/Group Title	Phase II Arm A: Phase I Then ENF 90mg SC BID	Phase II Arm B: Phase I Then ENF 180mg SC QD
Arm/Group Description	(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 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 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.
Measure Participants	9	5
Week 4 (<= 50 copies/mL)	5 17.2%	4 NaN
Week 4 (< 400 copies/mL)	6 20.7%	4 NaN
Week 8 (<= 50 copies/mL)	6 20.7%	4 NaN
Week 8 (< 400 copies/mL)	7 24.1%	4 NaN
Week 12 (<= 50 copies/mL)	6 20.7%	4 NaN
Week 12 (< 400 copies/mL)	7 24.1%	4 NaN
Week 16 (<= 50 copies/mL)	5 17.2%	3 NaN
Week 16 (< 400 copies/mL)	6 20.7%	4 NaN

6. Secondary Outcome

Title	CD4+ Lymphocyte Count Change From Baseline
Description	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.
Time Frame	Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	Phase II Arm A: Phase I Then ENF 90mg BID	Phase II Arm B: Phase I Then ENF 180mg QD
Arm/Group Description	(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 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 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.
Measure Participants	9	5
Phase I baseline to Week 1 of Phase II (n=8,5)	22	118.0
Phase I baseline to Week 12 of Phase II (n=7,4)	83.0	174.5
Phase I baseline to Week 16 of Phase II (n=6,4)	61.0	179.0

7. Secondary Outcome

Title	Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Time Frame	Phase I and II

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase I: ENF 90mg SC BID	Phase II - Arm A	Phase II - Arm B
Arm/Group Description	(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 I then ENF 90 mg SC BID	Phase I then ENF 180 mg SC QD
Measure Participants	29	9	5
Any type	92	100	100
Pain/discomfort	52	42.9	60
Erythema	80	71.4	100
Induration	80	100	100
Pruritus	44	28.6	20
Nodules	56	57.1	80
Ecchymosis	40	14.3	20

Adverse Events

Time Frame	Phase I Day 1 through Week 12 & Phase II Day 1 through Week 16
Arm/Group Title	Phase I: ENF 90mg SC BID		Phase II Arm A: Phase I Then ENF 90mg SC BID		Phase II Arm B: Phase I Then ENF 180mg SC QD
Arm/Group Description	(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 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 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.
All Cause Mortality
	Phase I: ENF 90mg SC BID		Phase II Arm A: Phase I Then ENF 90mg SC BID		Phase II Arm B: Phase I Then ENF 180mg SC QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Phase I: ENF 90mg SC BID		Phase II Arm A: Phase I Then ENF 90mg SC BID		Phase II Arm B: Phase I Then ENF 180mg SC QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/29 (13.8%)		0/9 (0%)		0/5 (0%)
Blood and lymphatic system disorders
Anemia	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
General disorders
Death	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Infections and infestations
Cytomegalovirus viraemia	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Nervous system disorders
Cerebrovascular accident	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Transient ischaemic attack	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Psychiatric disorders
Suicidal ideation	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Renal and urinary disorders
Renal failure	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary mass	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Phase I: ENF 90mg SC BID		Phase II Arm A: Phase I Then ENF 90mg SC BID		Phase II Arm B: Phase I Then ENF 180mg SC QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/29 (6.9%)		0/9 (0%)		0/5 (0%)
Gastrointestinal disorders
Diarrhoea	1/29 (3.4%)		0/9 (0%)		0/5 (0%)
Skin and subcutaneous tissue disorders
Rash morbilliform	1/29 (3.4%)		0/9 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.