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.

Condition	Treatment or Intervention
HIV Infections	Drug: Emtricitabine  Drug: Lopinavir/Ritonavir  Drug: Tenofovir disoproxil fumarate

Further Study Details: 

Expected Total Enrollment:  150

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 (FTC), lopinavir/ritonavir (LPV/RTV), and tenofovir disoproxil fumarate (TDF) 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 and TDF once daily and LPV/RTV twice daily. Group 2 will receive no treatment for the duration of the study. 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 and pill counts 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria for Step 1:

• Recently infected with HIV
• CD4 count of 350 cells/mm3 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 methods 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
• Certain medications within 21 days prior to study entry
• 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
• Pregnant or breastfeeding

California
      University of California-San Diego, San Diego,  California,  92103,  United States
      University of California-San Francisco, San Francisco,  California,  94110,  United States
Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80262-3706,  United States
Georgia
      Emory University, Atlanta,  Georgia,  30308,  United States
Massachusetts
      Massachusetts General Hospital-Partners AIDS Research, Boston,  Massachusetts,  02114,  United States
      Brigham and Womens Hospital, Boston,  Massachusetts,  02115,  United States
Michigan
      Henry Ford Hospital AIDS Clinic, Detroit,  Michigan,  48202,  United States
Missouri
      Washington University (St. Louis), St. Louis,  Missouri,  63108-2138,  United States
New York
      Aaron Diamond AIDS Research Center at Rockefeller, New York,  New York,  10021,  United States
      University of Rochester Medical Center, Rochester,  New York,  14642-0001,  United States
      Community Health Network, Inc., Rochester,  New York,  14642-0001,  United States
      SUNY - Buffalo (Rochester), Buffalo,  New York,  14215,  United States
      Beth Israel Medical Center, New York,  New York,  10003,  United States
      Columbia University, New York,  New York,  10032,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States
      University of North Carolina, Chapel Hill,  North Carolina,  27514,  United States
      The Moses H. Cone Memorial Hospital, Greensboro,  North Carolina,  27401-4001,  United States
      Wake County Department of Health, Chapel Hill,  North Carolina,  27514,  United States
Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States
Rhode Island
      The Miriam Hospital, Providence,  Rhode Island,  02906,  United States
      Rhode Island Hospital, Providence,  Rhode Island,  02906,  United States
      Stanley Street Treatment and Resource, Providence,  Rhode Island,  02906,  United States

Study chairs or principal investigators

Christine Hogan, MD,  Study Chair,  Division of Infectious Diseases, Columbia University College of Physicians and Surgeons   

Study ID Numbers:  AIEDRP AIN503/ ACTG A5217; AIEDRP AIN503; ACTG A5217
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  September 3, 2004
ClinicalTrials.gov Identifier:  NCT00090779
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08