• time to confirmed virologic failure (plasma HIV-1 RNA levels ≥1000 copies/ml [ Time Frame: at or after week 16 and before week 24, or ≥200 copies/ml at or after week 24) ] [ Designated as safety issue: No ]
  
• study medication toxicity-related discontinuation of any component of the initial randomized study regimen. [ Time Frame: anytime during treatment ] [ Designated as safety issue: Yes ]
  

• to compare virologic responses (confirmed plasma HIV-1 RNA <200 copies/ml and <50 copies/ml) in the two treatment arms. [ Time Frame: weeks 4, 8, 16, 24, 32, 40 and 48 ] [ Designated as safety issue: No ]
  
• evaluate immunologic response defined as increases in CD4+ and CD8+ cell counts in the two treatment arms [ Time Frame: weeks 4, 8, 16, 24, 32, 40 and 48 ] [ Designated as safety issue: No ]
  
• determine the safety and tolerability (proportion of subjects receiving study treatment) in the two treatment arms [ Time Frame: weeks 4, 8, 16, 24, 32, 40 and 48 ] [ Designated as safety issue: Yes ]
  

A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects.

HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC 200 mg/TDF 300 mg QD (Arm B).

Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry and entry. The average of these measurements will be used to establish their baseline values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.

Inclusion Criteria:

• Documented HIV Infection
• Genotypic resistance without major resistance mutations within 30 days
• Antiretroviral drug-naïve
• Screening HIV-1 RNA ≥5000
• Women of reproductive potential
• negative pregnancy test within 48 hours

Exclusion Criteria:

• Acute or recent HIV-1 infection
• Currently breast feeding
• Use of immunomodulators
• Evidence of major resistance mutations
• HBsAg positive
• Acute hepatitis of any etiology or clinically significant liver disease
• Current imprisonment or involuntary incarceration