Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02131233
• Date of registration: 02/05/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) onceMRK
• Scientific title: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects
• Date of first enrolment: May 23, 2014
• Target sample size: 802
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02131233
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, Chile, Colombia, France, Germany, Guatemala, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Peru, Philippines, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- HIV-1 positive

- Naïve to antiretroviral therapy including investigational antiretroviral agents

- Not of reproductive potential or, if of reproductive potential agrees to 1) true
abstinence, or 2) use of an acceptable method of birth control during the study

Exclusion Criteria:

- Use of recreational or illicit drugs or has recent history of drug or alcohol abuse or
dependence

- Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with an
agent that is active against HIV-1 including but not limited to adefovir, tenofovir,
entecavir, emtricitabine, or lamivudine

- Has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir
before the first dose of study drug

- Has participated in a study with an investigational compound or device within 30 days
or anticipates participating in such a study during this study

- Has used systemic immunosuppressive therapy or immune modulators within 30 days or is
anticipated to need them during the study (short courses of corticosteroids are
allowed)

- Requires or is anticipated to require any of the following prohibited medications
while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium,
magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of
Magnesia™

- Has significant hypersensitivity or other contraindication to any of the components of
the study drugs

- Has current, active diagnosis of acute hepatitis due to any cause

- Is pregnant, breastfeeding, or expecting to conceive during the study

- Female participant expecting to donate eggs or male participant expecting to donate
sperm during the study

- Is or has a family member (spouse or children) who is investigational staff or sponsor
staff directly involved in this trial



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Drug: Raltegravir

Drug: Placebo to Raltegravir

Drug: Placebo to Reformulated Raltegravir

Drug: Reformulated Raltegravir

Drug: TRUVADA™

Primary Outcome(s)

Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48 [Time Frame: Week 48]

Secondary Outcome(s)

Percentage of Participants With a SAE After 96 Weeks of Treatment [Time Frame: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)]

Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96 [Time Frame: Week 96]

Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96 [Time Frame: Up to Week 96]

Percentage of Participants With a Drug-Related AE at Week 48 [Time Frame: Up to Week 48]

Percentage of Participants With an AE After 96 Weeks of Treatment [Time Frame: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)]

Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48 [Time Frame: Up to Week 48]

Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment [Time Frame: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)]

Change From Baseline in CD4 Cell Count at Week 96 [Time Frame: Baseline and Week 96]

Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 [Time Frame: Baseline and Week 48]

Percentage of Participants With a Serious Adverse Event (SAE) at Week 48 [Time Frame: Up to Week 48]

Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment [Time Frame: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)]

Percentage of Participants With an Adverse Event (AE) at Week 48 [Time Frame: Up to Week 48]

Percentage of Participants With a Serious and Drug-Related AE at Week 48 [Time Frame: Up to Week 48]

Secondary ID(s)

0518-292

2013-001939-47

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02131233