• Log10 HIV-1 viral load [ Time Frame: At Weeks 72 and 76 ] [ Designated as safety issue: No ]
  
• Comparison of the log10 HIV-1 viral load for each Arm A participant with the log10 HIV-1 viral load for each Arm B participant [ Time Frame: At Weeks 72, 76, 36, and 40 ] [ Designated as safety issue: No ]
  
• Number of participants experiencing either a CDC category B or C diagnosis, grade 3 or 4 adverse event, treatment-limiting adverse event, or acute retroviral syndrome [ Time Frame: At Week 96 ] [ Designated as safety issue: Yes ]
  

• Log10 HIV-1 viral load [ Time Frame: At Weeks 36 and 96 ] [ Designated as safety issue: No ]
  
• CD4 and CD8 cells [ Time Frame: At Weeks 36, 72, and 96 ] [ Designated as safety issue: No ]
  
• Number of participants meeting clinical, virologic, or immunologic criteria for treatment initiation or continuation [ Time Frame: Throuhgout study ] [ Designated as safety issue: No ]
  
• Time from study entry in Arm B participants or from Week 36 in Arm A participants to meeting the clinical, virologic, or immunologic criteria for treatment initiation or continuation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Number of participants off treatment [ Time Frame: At Week 96 ] [ Designated as safety issue: No ]
  
• Number of participants on treatment who develop resistance to any component of the treatment regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Number of participants in each arm that develops major organ disease [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  

Combination antiretroviral therapy has resulted in significantly decreased morbidity and mortality, incidence of opportunistic infections, and hospitalizations in HIV infected people. However, because of long-term toxicities associated with long-term use of antiretrovirals and the persistence of virus in latent reservoirs, it is unclear when it is best to initiate therapy in recently infected individuals. This study will compare the virologic outcomes of adults recently infected with HIV who receive emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), coformulated as Truvada, and lopinavir/ritonavir (LPV/RTV), coformulated as Kaletra, with those who receive no treatment.

This study will last 96 weeks. Participants will be randomly assigned to one of two groups. For the first 36 weeks of the study, Group 1 will receive FTC/TDF once daily and LPV/RTV twice daily. Some Group 1 participants will receive a different ART regimen as determined by the participant and study staff, if appropriate. Group 2 will receive no treatment for the duration of the study. At Week 37, participants from both Group 1 and 2 will be offered treatment continuation or initiation until Week 96 if they have a high viral load, low CD4 count, or are experiencing HIV-related symptoms. Study visits will occur at screening, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 37, 38, 40, and every 4 weeks thereafter. Clinical assessment and blood collection will occur at all visits. Urine tests will occur at selected visits. Participants will be asked to complete an adherence questionnaire at Weeks 12, 24, and 36.

Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study.

Per a letter of amendment dated September 4, 2009 this protocol has been terminated as originally written witht he exception of those participants in Group 1 in the middle of the first 36 weeks of treatment. Those participants may continue on treatment through the study until the end of the 36 weeks. At this point treatment decisions should be make on best practice guidelines. In addition, the study duration will be extended to include a 5 year follow up of participants who have yet to initiate long-term antiretrovial therapy.