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

This study has been terminated.

(This study was terminated early due to poor enrollment.)

Sponsor:

Collaborator:

Trimeris

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00488059

First received: June 18, 2007

Last updated: July 18, 2011

Last verified: July 2011

History of Changes

Results First Received: November 11, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: enfuvirtide [Fuzeon] Drug: Optimized background ARV Drug: Integrase inhibitor

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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)

Participant Flow for 3 periods

Period 1: Phase I: ENF 90mg SC BID

	Phase I	Phase II - Arm A	Phase II - Arm B
STARTED	29	0	0
COMPLETED	14	0	0
NOT COMPLETED	15	0	0

Period 2: Phase II Arm A:Phase I Then ENF 90mg BID

	Phase I	Phase II - Arm A	Phase II - Arm B
STARTED	0	9	0
COMPLETED	0	7	0
NOT COMPLETED	0	2	0

Period 3: Phase II Arm B:Phase I Then ENF 180mg QD

	Phase I	Phase II - Arm A	Phase II - Arm B
STARTED	0	0	5
COMPLETED	0	0	1
NOT COMPLETED	0	0	4

Baseline Characteristics

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Reporting Groups

	Description
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).

Baseline Measures

	Phase 1: ENF 90mg SC BID
Number of Participants [units: participants]	29
Age [units: years] Mean ± Standard Deviation	45.4 ± 10.30
Gender [units: participants]
Female	5
Male	24

Outcome Measures

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1. Primary:

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

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2. Primary:

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 ]

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Measure Type	Primary
Measure Title	Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16
Measure Description	No text entered.
Time Frame	Week II-16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population

Reporting Groups

	Description
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.
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.

Description

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.

Phase II Arm B: Phase I Then ENF 180mg SC QD

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.

Measured Values

	Phase II Arm A: Phase I Then ENF 90 mg SC BID	Phase II Arm B: Phase I Then ENF 180mg SC QD
Number of Participants Analyzed [units: participants]	9	5
Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16 [units: participants]	5	3

No statistical analysis provided for Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16

3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00488059 History of Changes
Other Study ID Numbers:	ML20837
Study First Received:	June 18, 2007
Results First Received:	November 11, 2009
Last Updated:	July 18, 2011
Health Authority:	United States: Food and Drug Administration

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