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UBMD Physicians' Group

Clinical Trials

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

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.

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

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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

Investigator

Alyssa Shon, M.D.

Contact Information

Name: Alyssa Shon, MD
Phone: 898-4119
Email: alyssash@buffalo.edu