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 : March 30, 2015
The primary objective of this study is:
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 human immunodeficiency virus(HIV) (< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, < 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen.
HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: raltegravir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||September 2009|
Experimental: 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.
This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.
Other Name: MK-0518, Isentress
- Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. [ Time Frame: 24 Weeks ]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.
- Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 [ Time Frame: 24 Weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529243
|United States, California|
|Anaheim, California, United States, 92807|
|Hayward, California, United States, 95454|
|Kaiser Los Angeles|
|Los Angeles, California, United States, 90027|
|Kaiser West Los Angeles|
|Los Angeles, California, United States, 90034|
|Kaiser Panorama City|
|Panorama City, California, United States, 91402|
|Kaiser San Francisco|
|San Francisco, California, United States, 94118|
|Kaiser Santa Clara|
|Santa Clara, California, United States, 95051|
|Kaiser Santa Clarita|
|Santa Clarita, California, United States, 91355|
|Principal Investigator:||William J Towner, MD||Kaiser Permanente|