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

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

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
No text entered.

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

Baseline Characteristics

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

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information