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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)

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ClinicalTrials.gov Identifier: NCT00529243
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : June 8, 2011
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
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
Enrollment 52

Recruitment Details 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  
Arm/Group Title MK-0518 (Raltegravir)
Hide Arm/Group Description Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Period Title: Overall Study
Started 52
Completed 49
Not Completed 3
Reason Not Completed
Adverse Event             1
Death             1
Relocated             1
Arm/Group Title MK-0518 (Raltegravir)
Hide Arm/Group Description Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
53
(40 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
4
   7.7%
Male
48
  92.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants
52
Time of Prior Antiretroviral Therapy Use  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
15
(7 to 22)
Number of Past Antiretrovials Used  
Mean (Full Range)
Unit of measure:  Medications
Number Analyzed 52 participants
15
(4 to 22)
Time on Enfuvirtide Therapy   [1] 
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 52 participants
997
(264 to 2457)
[1]
Measure Description: mean length of time on enfuvirtide therapy before change to MK-0518 (raltegravir)
1.Primary Outcome
Title Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.
Arm/Group Title MK-0518 (Raltegravir)
Hide Arm/Group Description:
Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
49
2.Secondary Outcome
Title Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24
Hide Description To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir.
Arm/Group Title MK-0518 (Raltegravir)
Hide Arm/Group Description:
Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Overall Number of Participants Analyzed 52
Mean (Full Range)
Unit of Measure: cells/mm^3
32
(-165 to 1362)
Time Frame 33 Weeks
Adverse Event Reporting Description Any adverse event (i.e., a new event or an exacerbation of a pre-existing condition) with an onset date after study drug administration up to the last day on study (including the follow-up, off study medication period of the study), should be recorded.
 
Arm/Group Title MK-0518 (Raltegravir)
Hide Arm/Group Description Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
All-Cause Mortality
MK-0518 (Raltegravir)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-0518 (Raltegravir)
Affected / at Risk (%) # Events
Total   3/52 (5.77%)    
Blood and lymphatic system disorders   
Septicemia   1/52 (1.92%)  1
Endocrine disorders   
Diabetic Ketoacidosis   1/52 (1.92%)  1
Gastrointestinal disorders   
Death  [1]  1/52 (1.92%)  1
Indicates events were collected by systematic assessment
[1]
Patient with history of gastroparesis & delayed emptying unrelated to his HIV disease died 12 weeks into the study, assessed due to worsening of malnourishment and dehydration not due to his antiretroviral medications or study participation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-0518 (Raltegravir)
Affected / at Risk (%) # Events
Total   12/52 (23.08%)    
Hepatobiliary disorders   
alanine aminotransferase (ALT)   6/52 (11.54%)  6
Nervous system disorders   
Fatigue   3/52 (5.77%)  3
Renal and urinary disorders   
serum creatinine elevation   3/52 (5.77%)  3
Indicates events were collected by systematic assessment
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.
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
ClinicalTrials.gov 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