HIV Resistance and Treatment Strategies
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this observational study is to characterize which immune system cells hide the
      latent reservoir of HIV by counting the number of latent HIV in different subsets of CD4
      cells. Observations will also be made on other possible mechanisms of HIV persistence by
      looking at cellular factors such as APOBEC3 and drug transporters. The purpose of this study
      is to develop new strategies to reduce and possibly eliminate the latent reservoir in HIV
      infected adults.
    

Detailed description: 
      Memory CD4 cells may provide a reservoir of latent HIV that cannot be completely eliminated
      using currently available anti-HIV medications. The overall goal of this observational study
      is to develop new strategies to eliminate the latent HIV reservoir in HIV infected
      individuals. CD4-cell subsets, cellular anti-HIV factors, and cellular drug transporters will
      be observed to determine which resting memory cells hide latent HIV and to determine the
      mechanisms responsible for the persistence of the latent HIV reservoir.

      This study will last for at least 3 years. The screening visit will include medical history,
      contact information, urine collection, and a physical exam. Participants will be assigned to
      one of five groups:

        -  Group 1 will consist of intensively studied adults initiating potentially suppressive
           drug therapy. At the screening visit, Group 1 participants will be given the option to
           either undergo blood draws or leukapheresis for all visits.

        -  Group 2 will consist of intensively studied, well-suppressed adults on highly active
           antiretroviral therapy (HAART). At the screening visit, Group 2 participants will be
           given the option to either undergo blood draws or leukapheresis for all visits.

        -  Group 3 will consist of nonintensively studied adults initiating potentially suppressive
           drug therapy. Group 3 participants will undergo blood draws at all visits.

        -  Group 4 will consist of nonintensively studied, well-suppressed adults on HAART. Group 4
           participants will undergo blood draws at all visits.

        -  Group 5 will consist of participants who are currently in the Merck Expanded Access
           Program receiving raltegravir. At the screening visit, Group 5 participants will be
           given the option to either undergo blood draws or leukapheresis for all visits.

      For all participants undergoing blood draws only, visits will occur every 3 months for about
      3 years. For patients undergoing leukapheresis, visits will occur every 6 months for about 3
      years. At each visit, blood collection, documentation of current HAART, and updating of
      contact information will occur. Participants are encouraged to provide additional blood
      samples to be stored at all visits.

      Participants in Groups 1, 2, or 5 may decline to be in the leukapheresis group at any time
      and will be given the option of continuing in the blood draw group or withdrawing completely
      from the study. If specimens are not obtained for any reason at any visit, participants in
      Groups 1, 2, or 5 will default to either Group 3 or Group 4. Antiretroviral medications will
      not be provided by this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the Comprehensive Care Clinic, a clinic that provides
        care exclusively to HIV patients from middle Tennessee and surrounding states. Participants
        are screened and identified with the inclusion and exclusion criteria from the computerized
        medical records system. If the medical charts are tagged, the study nurse will speak to the
        selected participant at the participant's following appointment.
      
Biospecimen description: 
      Plasma, white cells, and whole blood
    
Keywords: CD4-Positive T-Lymphocytes; Treatment Naive; Latent HIV Infections