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

Purpose

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.

Condition	Intervention	Phase
Human Immunodeficiency Virus	Drug: Comparator: raltegravir	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.
Number of Participants With One or More Adverse Events [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
Numbers of participants with one or more adverse events were summarized by race.
Number of Participants Who Discontinued Due to an Adverse Event [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
Numbers of participants who discontinued due to an adverse event were summarized by race.

Secondary Outcome Measures:

Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.
Mean Change From Baseline to Week 48 in HIV RNA [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.
Mean Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
Mean changes from baseline in CD4 cell counts were summarized by race at each time point.
Number of Participants Without Loss of Virologic Response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).


Enrollment:	209
Study Start Date:	October 2008
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 raltegravir	Drug: Comparator: raltegravir 400 mg tablets taken twice daily. Total treatment period is 48 weeks. Other Name: ISENTRESS

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764946

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

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.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00764946 History of Changes
Other Study ID Numbers:	0518-055 2008_555
Study First Received:	October 1, 2008
Results First Received:	February 13, 2012
Last Updated:	July 6, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Slow Virus Diseases Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016