• 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 at Weeks 72 and 76
• comparison of the log10 HIV-1 viral load for each Arm A participant at Weeks 72 and 76 with the log10 HIV-1 viral load for each Arm B participant at Weeks 36 and 40
• 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 by Week 96

• 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 ]

• Log10 HIV-1 viral load at Weeks 36 and 96
• CD4 and CD8 cells at Weeks 36, 72, and 96
• number of participants meeting clinical, virologic, or immunologic criteria for treatment initiation or continuation at any time during the study
• 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
• number of participants off treatment at Week 96
• number of participants on treatment who develop resistance to any component of the treatment regimen

Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.

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.

• Drug: Emtricitabine/ tenofovir disoproxil fumarate
• Drug: Lopinavir/Ritonavir

• Active Comparator: Group 1 will receive emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
• No Intervention: No Treatment

• Messer K, Vaida F, Hogan C. Robust analysis of biomarker data with informative missingness using a two-stage hypothesis test in an HIV treatment interruption trial: AIEDRP AIN503/ACTG A5217. Contemp Clin Trials. 2006 Jul 25; [Epub ahead of print]
• Fidler S, Oxenius A, Brady M, Clarke J, Cropley I, Babiker A, Zhang HT, Price D, Phillips R, Weber J. Virological and immunological effects of short-course antiretroviral therapy in primary HIV infection. AIDS. 2002 Oct 18;16(15):2049-54.
• Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. Epub 2004 Apr 30.
• Little SJ, Holte S, Routy JP, Daar ES, Markowitz M, Collier AC, Koup RA, Mellors JW, Connick E, Conway B, Kilby M, Wang L, Whitcomb JM, Hellmann NS, Richman DD. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med. 2002 Aug 8;347(6):385-94.
• Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. Review.

Inclusion Criteria for Step 1:

• Recently infected with HIV
• CD4 count of 350 cells/mm3 or more AND a CD4% of 14% or more within 21 days prior to study entry
• HIV viral load of 500 copies/ml or more within 21 days prior to study entry
• Ability and willingness to follow protocol requirements
• Willing to use acceptable forms of contraception

Exclusion Criteria for Step 1:

• Prior antiretroviral therapy. Participants who took antiretrovirals for postexposure prophylaxis more than one year prior to study entry are not excluded.
• CDC category B or C HIV disease
• History of pancreatitis or coronary artery disease
• Certain medications within 21 days prior to study entry. Participants who agree to receive an alternative ART regimen approved by the investigator will not be excluded.
• Previously received an investigational anti-HIV vaccine
• Current therapy with systemic corticosteroids. Patients who are taking a short course (less than 21 days) of corticosteroids are not excluded.
• Current therapy with systemic chemotherapeutic agents; nephrotoxic systemic agents; immunomodulatory treatments, including interleukin-2; or investigational agents
• Known allergy or sensitivity to study drugs or their formulations
• Current alcohol or drug use that, in the opinion of the investigator, would interfere with the study
• Serious medical or psychiatric illness that, in the opinion of the investigator, would interfere with the study
• Hepatitis B surface antigen positive within 21 days prior to study entry
• Known resistance to one or more components of the study drug regimen
• Pregnant or breastfeeding