A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibit... | NCT00488059

Status Module

Name	Class
Trimeris	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase I	Experimental	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] Drug: Optimized background ARV Drug: Integrase inhibitor
Phase II	Experimental	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 Drug: Integrase inhibitor Drug: enfuvirtide [Fuzeon]

Name	Type	Description	Arm Group Labels	Other Names
enfuvirtide [Fuzeon]	Drug	90 mg SC twice daily	Phase I
Optimized background ARV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL	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)	Between Week I-4 and Week I-12 of Phase I of the study
Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16		Week II-16

Secondary Outcomes

Measure	Description	Time Frame
Virologic Response Over Time in Phase I of the Study	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.	Weeks 4, 8 & 12
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Hobson City	Alabama	36201	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Phase 1: ENF 90mg SC BID	(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).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL

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)

Intent-to-treat population

Posted

Number

participants

Between Week I-4 and Week I-12 of Phase I of the study

ID	Title	Description
OG000	Phase I: ENF 90mg SC BID	(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).

Units	Counts
Participants	OG00029

Title

Denominators

Categories

Week 8

Title	Measurements
	OG0008

Week 12

Title	Measurements
	OG0005

Week 16

Secondary

Virologic Response Over Time in Phase I of the Study

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.

Intent-to-treat population

Posted

Number

participants

Weeks 4, 8 & 12

ID	Title	Description
OG000	Phase I: ENF 90mg SC BID	(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).

Units	Counts
Participants	OG000

Primary

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

Intent-to-treat population

Posted

Number

participants

Week II-16

ID	Title	Description
OG000	Phase II Arm A: Phase I Then ENF 90 mg SC BID	(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.
OG001	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.

Secondary

HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study

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

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.

Posted

Mean

Standard Deviation

log10 copies/mL

Baseline and Weeks 4, 8, 12 & LOCF

ID	Title	Description
OG000	Phase I: ENF 90mg SC BID	(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).

Units	Counts
Participants	OG000

Secondary

Virologic Response Over Time in Phase II of the Study

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.

intent-to-treat population

Posted

Number

participants

Weeks II-4, 8, 12 & 16

ID	Title	Description
OG000	Phase II Arm A: Phase I Then ENF 90mg SC BID	(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.
OG001	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.

Secondary

CD4+ Lymphocyte Count Change From Baseline

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.

Intent-to-treat

Posted

Median

Full Range

cells/mm3

Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF

ID	Title	Description
OG000	Phase II Arm A: Phase I Then ENF 90mg BID	(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.
OG001	Phase II Arm B: Phase I Then ENF 180mg 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.

Secondary

Percentage of Patients With Ongoing Injection Site Reactions (ISRs)

Posted

Number

Percentage of patients

Phase I and II

ID	Title	Description
OG000	Phase I: ENF 90mg SC BID	(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).
OG001	Phase II - Arm A	Phase I then ENF 90 mg SC BID
OG002	Phase II - Arm B	Phase I then ENF 180 mg SC QD

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase I: ENF 90mg SC BID	(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).	4	29	2	29
EG001	Phase II Arm A: Phase I Then ENF 90mg SC BID	(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.	0	9	0	9
EG002	Phase II Arm B: Phase I Then ENF 180mg SC QD	(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.	0	5	0	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cerebrovascular accident	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Death	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Renal failure	Renal and urinary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk

Ancestor Terms

ID	Term
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D015700	HIV Envelope Protein gp41
D014760	Viral Fusion Proteins
D050576	Membrane Fusion Proteins
D008565	Membrane Proteins
D011506	Proteins
D015488	HIV Antigens
D000956	Antigens, Viral
D014764	Viral Proteins
D054299	env Gene Products, Human Immunodeficiency Virus
D015686	Gene Products, env
D012191	Retroviridae Proteins
D054298	Human Immunodeficiency Virus Proteins
D014759	Viral Envelope Proteins
D015678	Viral Structural Proteins
D000941	Antigens
D001685	Biological Factors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment		EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Non-systematic Assessment		EG0001 affected29 at risk EG0010 affected9 at risk EG0020 affected5 at risk