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Comparator: Placebo to MK-0518
MK-0518 is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA.
MK-0518 is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into human DNA. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients.
At a glance
| Generic name | Comparator: Placebo to MK-0518 |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
MK-0518 (raltegravir) inhibits HIV integrase, an enzyme essential for viral replication. By blocking integrase-mediated strand transfer, the drug prevents integration of viral DNA into the host genome, thereby blocking HIV replication. This represents a novel class of antiretroviral therapy targeting a distinct step in the HIV life cycle.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced patients
Common side effects
- Diarrhea
- Nausea
- Headache
- Fatigue
- Elevated creatine kinase
Key clinical trials
- 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) (PHASE3)
- Effect of Raltegravir on Endothelial Function in HIV-Infected Patients (PHASE4)
- MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED) (PHASE3)
- A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT) (PHASE3)
- MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED) (PHASE3)
- A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071) (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019) (PHASE3)
- Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comparator: Placebo to MK-0518 CI brief — competitive landscape report
- Comparator: Placebo to MK-0518 updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI