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Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population

  • Study HIC#:1111009338
  • Last Updated:07/15/2021

Primary:

To describe clinical, immunological, and virological characteristics of persons with acute HIV infection To identify and follow volunteers who may be candidates for future HIV intervention or treatment protocols due to diagnosis of HIV during acute infection
  1. To describe demographics,_aRG-behavioral risk factors and clinical signs and symptoms for those identified with acute HIV infection
  2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid.
  3. To describe the number and characteristics of sexual contacts
  4. To describe the willingness of acutelv HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)
  5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment
  6. To describe T. Band NK cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut Hellsimmunity during follow up
  7. To describe T and B cell distribution, phenotype and function in lymph node biopsy samples in acute HIV infection and to describe differences seen in these parameters during study follow up
  8. To understand the association between different HIV reservoir biomarkers
  9. To characterize the composition and evolution of the gastrointestinal microbial population in acutely HIV-infected subjects
  10. To describe virologic and immunologic parameters by different acute HIV infection staging systems (Fiebig, and the 4thG or other staging systems)
  11. To understand the effects of early antiretroviral therapy on the outcomes mentioned above
  12. To archive samples for future investigations including determination of viral burden and evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments
  • Age18 years and older
  • GenderBoth
  • Start Date12/07/2011
  • End Date12/09/2021

Trial Purpose and Description

To describe clinical, immunological, and virological characteristics of persons with acute HIV infection

  1. To describe demographics and behavioral risk factors for those identified with acute HIV infection
  2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid.
  3. To describe the number and characteristics of sexual contacts
  4. To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)
  5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment
  6. To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up
  7. To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments

Eligibility Criteria

Inclusion Criteria:

  1. Age >18 years old
  2. Have protocol-defined acute HIV-1 infection (Tested 4th generation HIV EIA negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and NAT positive)
  3. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
  4. Availability for follow-up for the planned study duration

Exclusion Criteria:

  1. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.

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