Status:
TERMINATED
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).
Eligibility Criteria
Inclusion
- Patient is at least 18 years of age
- Patient is human immunodeficiency virus (HIV) positive
- Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
- Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
- Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen
Exclusion
- Patient is or plans to become pregnant, or is nursing a child
- Patient plans to donate eggs or impregnate/donate sperm
- Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
- Patient is currently receiving a second protease inhibitor in addition to KALETRA
- Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
- Patient has used another experimental HIV-integrase inhibitor
- Patient has a current (active) diagnosis of acute hepatitis due to any cause
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00443729
Start Date
May 1 2007
End Date
April 1 2009
Last Update
March 21 2017
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