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A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)

NCT01213316 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 451

Last updated 2016-05-23

Study results available
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Summary

This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks. Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug. The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load \< 50 copies/mL after 48 weeks of treatment with Raltegravir.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Raltegravir

Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks

DRUG

Raltegravir

Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213316 on ClinicalTrials.gov