NCT00105157

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Mar 2005

Typical duration for phase_2 hiv-infections

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 12, 2010

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

1.6 years

First QC Date

March 8, 2005

Results QC Date

September 14, 2009

Last Update Submit

December 3, 2015

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24

    Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients

    Baseline and Week 24

Secondary Outcomes (43)

  • Number of Patients With Virologic Responses at Week 24

    24 weeks

  • Change From Baseline in CD4 Cell Count at Week 24

    Baseline and Week 24

  • Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks

    48 weeks

  • Number of Patients With Serious CAEs at 48 Weeks

    48 weeks

  • Number of Patients With Drug-related CAEs at 48 Weeks

    48 weeks

  • +38 more secondary outcomes

Other Outcomes (2)

  • Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies

    Baseline and Week 168

  • Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies

    Baseline and Week 168

Study Arms (4)

1

EXPERIMENTAL

MK0518 200 mg

Drug: Comparator: MK0518

2

EXPERIMENTAL

MK0518 400 mg

Drug: MK0518

3

EXPERIMENTAL

MK0518 600 mg

Drug: MK0518

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Comparator: MK0518DRUG

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

Also known as: MK0518
1
MK0518DRUG

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

2
PlaceboDRUG

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

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patient less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17434401BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Due to a 3:1 randomization of MK-0518 to placebo and more discontinuations for placebo in the doubleblind phase, exposure for MK-0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2005

First Posted

March 9, 2005

Study Start

March 1, 2005

Primary Completion

October 1, 2006

Study Completion

July 1, 2009

Last Updated

December 4, 2015

Results First Posted

April 12, 2010

Record last verified: 2015-12