MedDataX Logo

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

NCT ID: NCT00377065

Last Updated: 2016-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia

NCT00618371

HIV Infection
COMPLETED NA

Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

NCT00529243

HIV Infections
COMPLETED PHASE3

Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load

NCT00515827

HIV Infections
COMPLETED PHASE2

Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)

NCT01814722

Human Immunodeficiency Virus
TERMINATED

Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression

NCT00554398

HIV Infections
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

raltegravir

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK0518 ISENTRESS™

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MK0518-023

Identifier Type: -

Identifier Source: secondary_id

2006_031

Identifier Type: -

Identifier Source: secondary_id

0518-023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MK-0518 Intensification And HDAC Inhibition In Depletion Of Resting CD4+ T Cell HIV Infection
NCT00614458 TERMINATED PHASE2
A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen
NCT00749580 COMPLETED NA
Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)
NCT01048671 COMPLETED
Integrase Inhibitor (MK-0518) Viral Decay
NCT00520897 COMPLETED PHASE2
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
NCT01266902 COMPLETED PHASE3
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy
NCT00709397 TERMINATED
Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load
NCT00454337 COMPLETED PHASE3
Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery
NCT00562510 TERMINATED PHASE3
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
NCT00537394 COMPLETED PHASE3
Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
NCT01245101 TERMINATED PHASE4
Effects of Intensive cART During Acute/Early HIV Infection
NCT01154673 COMPLETED PHASE2/PHASE3
Research In Viral Eradication of HIV Reservoirs
NCT02336074 COMPLETED PHASE2
Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1
NCT00781287 TERMINATED PHASE4
Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8558 Monotherapy in Anti-Retroviral-Naïve HIV-1 Infected Participants (MK-8558-002)
NCT03859739 COMPLETED PHASE1
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01475838 COMPLETED PHASE3
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
NCT01363011 COMPLETED PHASE3
Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01533259 COMPLETED PHASE3
Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen
NCT00738569 COMPLETED NA
Accelerated ART Initiation for PWHIV Who Are Out of Care
NCT06374758 RECRUITING PHASE4
Raltegravir as Early Therapy in African-Americans Living With HIV Study
NCT00667433 COMPLETED PHASE1
R5 Integrase Study in HIV-1 Naive Patients
NCT01204905 COMPLETED NA
Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1
NCT00807443 COMPLETED PHASE2
RAL+ATV/r in Comparison With TDF/FTC (or 3TC) +ATV/r in HIV Infected Patients
NCT01829802 UNKNOWN PHASE4
Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
NCT00887653 COMPLETED PHASE3
Ex Vivo Characterization and Targeting of the Latent HIV Infected Reservoir to Cure HIV
NCT05215704 RECRUITING