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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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
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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
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
    MK-0518 (Raltegravir)  
STARTED     52  
COMPLETED     49  
NOT COMPLETED     3  
Adverse Event                 1  
Death                 1  
Relocated                 1  



  Baseline Characteristics
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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
  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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Measure Type Primary
Measure Title Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
Measure Description To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.
Time Frame 24 Weeks  
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.
Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.

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.

Measured Values
    MK-0518 (Raltegravir)  
Number of Participants Analyzed  
[units: participants]
  52  
Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.  
[units: participants]
  49  

No statistical analysis provided for Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.



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
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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
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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
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