Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects (CHEER)

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT00529243

First received: September 12, 2007

Last updated: June 9, 2011

Last verified: June 2011

History of Changes

Results First Received: May 9, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Intervention:	Drug: raltegravir

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
A multicenter study that enrolled patients from 11 Kaiser Permanente Human Immunodeficiency Virus (HIV) clinics in California. 54 patients were screened. Two patients did not meet protocol inclusion criteria.

Pre-Assignment Details

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

	Description
MK-0518 (Raltegravir)	Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.

Participant Flow: Overall Study

	MK-0518 (Raltegravir)
STARTED	52
COMPLETED	49
NOT COMPLETED	3
Adverse Event	1
Death	1
Relocated	1

Baseline Characteristics

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Reporting Groups

	Description
MK-0518 (Raltegravir)	Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.

Baseline Measures

	MK-0518 (Raltegravir)
Number of Participants [units: participants]	52
Age [units: years] Mean ( Full Range )	53 ( 40 to 71 )
Gender [units: participants]
Female	4
Male	48
Region of Enrollment [units: participants]
United States	52
Time of Prior Antiretroviral Therapy Use [units: years] Mean ( Full Range )	15 ( 7 to 22 )
Number of Past Antiretrovials Used [units: medications] Mean ( Full Range )	15 ( 4 to 22 )
Time on Enfuvirtide Therapy ^[1] [units: days] Mean ( Full Range )	997 ( 264 to 2457 )

[1]	mean length of time on enfuvirtide therapy before change to MK-0518 (raltegravir)

Outcome Measures

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1. Primary:

Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. [ Time Frame: 24 Weeks ]

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2. Secondary:

Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 [ Time Frame: 24 Weeks ]

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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:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
A limitation of our study was the lack of a separate control arm. However, patients did serve as their own control by virtue of at least 6 months of HIV-1 ribonucleic acid(RNA)levels below the level of quantification before enrollment in the study.

Results Point of Contact:

Name/Title: William Towner, MD
Organization: Kaiser Permanente
phone: 323-783-7855
e-mail: William.J.Towner@KP.org

No publications provided

Responsible Party:	William Towner, MD, Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00529243 History of Changes
Other Study ID Numbers:	4908
Study First Received:	September 12, 2007
Results First Received:	May 9, 2011
Last Updated:	June 9, 2011
Health Authority:	United States: Food and Drug Administration

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