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Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

NCT ID: NCT00105157

Last Updated: 2015-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-07-31

Brief Summary

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This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

Detailed Description

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Conditions

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HIV Infections Acquired Immunodeficiency Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

MK0518 200 mg

Group Type EXPERIMENTAL

Comparator: MK0518

Intervention Type DRUG

MK0518 oral tablets 200 mg b.i.d, for 24 weeks

2

MK0518 400 mg

Group Type EXPERIMENTAL

MK0518

Intervention Type DRUG

MK0518 oral tablets 400 mg b.i.d, for 24 weeks

3

MK0518 600 mg

Group Type EXPERIMENTAL

MK0518

Intervention Type DRUG

MK0518 oral tablets 600 mg b.i.d, for 24 weeks

4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to MK0518, oral tablet b.i.d, for 24 weeks

Interventions

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Comparator: MK0518

MK0518 oral tablets 200 mg b.i.d, for 24 weeks

Intervention Type DRUG

MK0518

MK0518 oral tablets 400 mg b.i.d, for 24 weeks

Intervention Type DRUG

MK0518

MK0518 oral tablets 600 mg b.i.d, for 24 weeks

Intervention Type DRUG

Placebo

Placebo to MK0518, oral tablet b.i.d, for 24 weeks

Intervention Type DRUG

Other Intervention Names

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MK0518

Eligibility Criteria

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Inclusion Criteria

* Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
* Patient must be currently on antiretroviral therapy (ART)

Exclusion Criteria

* Patient less than 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2.

Reference Type BACKGROUND
PMID: 17434401 (View on PubMed)

Other Identifiers

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MK0518-005

Identifier Type: -

Identifier Source: secondary_id

2005_007

Identifier Type: -

Identifier Source: secondary_id

0518-005

Identifier Type: -

Identifier Source: org_study_id