A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)

NCT00764946 | Completed Phase 3 Results

• 2 other identifiers: 0518-0552008_555
• Study Type: interventional
• Target: 209
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

  Numbers of participants with HIV RNA copies \<50 copies/mL were summarized by race for each time point.

  Week 48

• Number of Participants With One or More Adverse Events

  Numbers of participants with one or more adverse events were summarized by race.

  Week 48

• Number of Participants Who Discontinued Due to an Adverse Event

  Numbers of participants who discontinued due to an adverse event were summarized by race.

  Week 48

Secondary Outcomes (4)

• Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48

  Week 48

• Mean Change From Baseline to Week 48 in HIV RNA

  Baseline and Week 48

• Mean Change From Baseline to Week 48 in CD4 Cell Count

  Baseline and Week 48

• Number of Participants Without Loss of Virologic Response

  Week 48

Study Arms (1)

1

EXPERIMENTAL

raltegravir

Drug: Comparator: raltegravir

Interventions

Comparator: raltegravir DRUG

400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Also known as: ISENTRESS

1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is HIV positive
• Patient agrees to use (or have their partner use) birth control as defined by the study doctor

You may not qualify if:

• If female, pregnant or breastfeeding
• Patient has used an investigational agent in the last 30 days
• Patient has acute hepatitis
• Patient has received MK0518 (raltegravir) before
• Patient has used another experimental HIV-integrase inhibitor

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Squires KE, Bekker LG, Eron JJ, Cheng B, Rockstroh JK, Marquez F, Kumar P, Thompson M, Campo RE, Mounzer K, Strohmaier KM, Lu C, Rodgers A, Jackson BE, Wenning LA, Robertson M, Nguyen BY, Sklar P; REALMRK Investigators. Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study. AIDS Res Hum Retroviruses. 2013 Jun;29(6):859-70. doi: 10.1089/AID.2012.0292. Epub 2013 Feb 26.

  PMID: 23351187 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharpe & Dohme Corp

ClinicalTrialsDisclosure@merck.com

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 21, 2017
• Results First Posted: April 12, 2012

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share