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) (onceMRK)

• Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ]
  CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values.
• Percentage of Participants Achieving <40 Copies/mL HIV-1 RNA at Week 96 [ Time Frame: Week 96 ]
  From blood samples collected at week 96, HIV-1 RNA levels will be determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL.
• Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline and Week 96 ]
  CD4 cells will be counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values.
• Percentage of Participants With an Adverse Event (AE) at Week 48 [ Time Frame: Up to Week 48 ]
  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
• Percentage of Participants With a Drug-Related AE at Week 48 [ Time Frame: Up to Week 48 ]
  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.
• Percentage of Participants With a Serious Adverse Event (SAE) at Week 48 [ Time Frame: Up to Week 48 ]
  A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
• Percentage of Participants With a Serious and Drug-Related AE at Week 48 [ Time Frame: Up to Week 48 ]
  A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.
• Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48 [ Time Frame: Up to Week 48 ]
  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE
• Percentage of Participants With an AE at Week 96 [ Time Frame: Up to Week 96 ]
  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
• Percentage of Participants With a Drug-Related AE at Week 96 [ Time Frame: Up to Week 96 ]
  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.
• Percentage of Participants With a SAE at Week 96 [ Time Frame: Up to Week 96 ]
  A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
• Percentage of Participants With a Serious and Drug-Related AE at Week 96 [ Time Frame: Up to Week 96 ]
  A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician will evaluate whether or not a SAE is drug-related.
• Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 96 [ Time Frame: Up to Week 96 ]
  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

• Change from Baseline in Cluster of Differentiation (CD4) Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ]
• Percentage of Participants Achieving <40 Copies/mL HIV-1 RNA at Week 96 [ Time Frame: Week 96 ]
• Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline and Week 96 ]
• Percentage of Participants with an Adverse Experience [ Time Frame: Up to Week 48 ]
• Percentage of Participants with a Drug-Related Adverse Experience [ Time Frame: Up to Week 48 ]
• Percentage of Participants with a Serious Adverse Experience [ Time Frame: Up to Week 48 ]
• Percentage of Participants with a Serious and Drug-Related Adverse Experience [ Time Frame: Up to Week 48 ]
• Percentage of Participants Discontinued from Drug Therapy Due to an Adverse Experience [ Time Frame: Up to Week 48 ]
• Percentage of Participants with an Adverse Experience [ Time Frame: Up to Week 96 ]
• Percentage of Participants with a Drug-Related Adverse Experience [ Time Frame: Up to Week 96 ]
• Percentage of Participants with a Serious Adverse Experience [ Time Frame: Up to Week 96 ]
• Percentage of Participants with a Serious and Drug-Related Adverse Experience [ Time Frame: Up to Week 96 ]
• Percentage of Participants Discontinued from Drug Therapy Due to an Adverse Experience [ Time Frame: Up to Week 96 ]

• Drug: Reformulated Raltegravir
  Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily
• Drug: Raltegravir
  Raltegravir 400 mg tablet orally twice daily
• Drug: TRUVADA™
  Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)
• Drug: Placebo to Reformulated Raltegravir
  Placebo to reformulated raltegravir 2 tablets orally once daily
• Drug: Placebo to Raltegravir
  Placebo to raltegravir 1 tablet orally twice daily

• Experimental: Reformulated Raltegravir
  Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
  Interventions:

  • Drug: Reformulated Raltegravir
  • Drug: TRUVADA™
  • Drug: Placebo to Raltegravir
• Active Comparator: Raltegravir
  Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
  Interventions:

  • Drug: Raltegravir
  • Drug: TRUVADA™
  • Drug: Placebo to Reformulated Raltegravir

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