None listed
Conditions
Interventions
Group 1: MK-1439A q.d.
MK-1439A is a single-tablet, fixed-dose regimen (FDR) containing MK-1439 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg.
Group 2: ATRIPLA™ q.d.
AT
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1 Be at least 18 years of age 2 Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial 3 Be HIV-1 positive as determined by a positive result on an enzyme-immunoassay, have screening plasma HIV-1 RNA ≥1000 copies/mL within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment 4 Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents. 5 Have the following laboratory values at screening: Alkaline phosphatase ≤3.0 x upper limit of normal; AST (SGOT) and ALT (SGPT) ≤5.0 x upper limit of normal 6 Have a calculated creatinine clearance at the time of screening ≥ 50 mL/min, based on the Cockcroft-Gault equation 7 In the opinion of the investigator, be considered clinically stable with no signs or symptoms of active infection at the time of entry into the study 8 Be highly unlikely to become pregnant or to impregnate a partner (Male or female who is not of reproductive potential or male or female who is of reproductive potential and agrees to use acceptable methods of contraception
Exclusion criteria
Exclusion criteria: 1 Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject’s participation for the full duration of the study 2 Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence 3 Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 4 Has documented or known resistance to study drugs 5 Has participated or will participate in a study with an investigational compound/device within 30 days prior to signing informed consent or during the study 6 Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study. 7 Requires or is anticipated to require any of the prohibited medications noted in the protocol 8 Has significant hypersensitivity or other contraindication to any of the components of the study drugs 9 Has a current (active) diagnosis of acute hepatitis due to any cause 10 Is pregnant, breastfeeding, or expecting to conceive 11 is female and is expecting to donate eggs or is male and is expecting to donate sperm (at any time during the study) 12 is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial
Countries
Australia, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Germany, Guatemala, Israel, Mexico, Netherlands, New Zealand, Peru, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed