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

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764946
• Other study ID #: 0518-055
• Secondary ID: 2008_555
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2008
• Last updated: July 6, 2015
• Start date: October 2008
• Est. completion date: February 2011

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Comparator: raltegravir
400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of Participants With One or More Adverse Events	Numbers of participants with one or more adverse events were summarized by race.	Week 48	Yes
Primary	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	Yes
Secondary	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.	Week 48	No
Secondary	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.	Baseline and Week 48	No
Secondary	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.	Baseline and Week 48	No
Secondary	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).	Week 48	No