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


  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 ]

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