Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
