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

Merck Sharp & Dohme LLC209 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

209

Conditions

Human Immunodeficiency Virus

Interventions

Comparator: raltegravirDRUG

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Week 48

Number of Participants With One or More Adverse Events

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

Time frame: 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.

Time frame: Week 48

Secondary Outcomes

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

Numbers of participants with HIV RNA copies \<400 copies/mL were summarized by race for each time point.

Time frame: Week 48

Mean Change From Baseline to Week 48 in HIV RNA

Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.

Time frame: Baseline and Week 48

Mean Change From Baseline to Week 48 in CD4 Cell Count

Mean changes from baseline in CD4 cell counts were summarized by race at each time point.

Time frame: Baseline and Week 48

Number of Participants Without Loss of Virologic Response

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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.