Trial record 19 of 35 for:    " August 29, 2007":" September 28, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00529243
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : June 8, 2011
Last Update Posted : August 7, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kaiser Permanente

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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)
Adverse Event                1 
Death                1 
Relocated                1 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
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) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (40 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4   7.7% 
Male      48  92.3% 
Region of Enrollment 
[Units: Participants]
United States   52 
Time of Prior Antiretroviral Therapy Use 
[Units: Years]
Mean (Full Range)
 (7 to 22) 
Number of Past Antiretrovials Used 
[Units: Medications]
Mean (Full Range)
 (4 to 22) 
Time on Enfuvirtide Therapy [1] 
[Units: Days]
Mean (Full Range)
 (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 ]

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

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: William Towner, MD
Organization: Kaiser Permanente
phone: 323-783-7855

Responsible Party: Kaiser Permanente Identifier: NCT00529243     History of Changes
Other Study ID Numbers: 4908
First Submitted: September 12, 2007
First Posted: September 14, 2007
Results First Submitted: May 9, 2011
Results First Posted: June 8, 2011
Last Update Posted: August 7, 2018