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NCT00377065 Clinical Trial

Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

HIV Infections Clinical Trial

Official title:
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT00377065
Other study ID # 0518-023
Secondary ID MK0518-0232006_0
Status Approved for marketing
Phase N/A
First received September 14, 2006
Last updated March 22, 2016

Study information
Verified date March 2016
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

This is a treatment use study to provide early access to MK0518 for the treatment of HIV-1 infection in patients who have limited or no treatment options due to virological failure, resistance, or intolerance to multiple antiretroviral regimens. Enrollment in this study is patient driven. Investigators are not proactively assigned. There is no target sample size and duration of the study is indefinite. For information on how to enroll in the study, see link below.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- HIV positive patients who have limited or no treatment options and have documented resistance

Exclusion Criteria:

- Patient has previously been on MK0518 therapy

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• raltegravir
raltegravir 400 mg P.O. bid tablet twice daily for 12 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.
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