Phase 3
Completed N=802
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)
Source: ClinicalTrials.gov NCT02131233 ↗Enrolled (actual)
802
Serious AEs
11.7%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48 — 88.9; 88.3 Percentage of participants
Summary
To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48 |
88.9; 88.3 | — |
| SECONDARY Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96 |
81.5; 80.1 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 |
232.0; 234.1 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 96 |
261.6; 262.2 | — |
| SECONDARY Percentage of Participants With an Adverse Event (AE) at Week 48 |
83.2; 88.0 | — |
| SECONDARY Percentage of Participants With an AE After 96 Weeks of Treatment |
90.8; 94.0 | — |
| SECONDARY Percentage of Participants With a Drug-Related AE at Week 48 |
25.0; 27.1 | — |
| SECONDARY Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment |
26.4; 28.6 | — |
| SECONDARY Percentage of Participants With a Serious Adverse Event (SAE) at Week 48 |
6.2; 9.4 | — |
| SECONDARY Percentage of Participants With a SAE After 96 Weeks of Treatment |
9.6; 15.8 | — |
| SECONDARY Percentage of Participants With a Serious and Drug-Related AE at Week 48 |
0.2; 0.8 | — |
| SECONDARY Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment |
0.2; 0.8 | — |
| SECONDARY Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48 |
1.1; 2.3 | — |
| SECONDARY Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96 |
1.3; 2.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02131233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.