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Specimen Repository for HIV Immunopathogenesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579381
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
AIDS Healthcare Foundation

Study Description
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Brief Summary:
Specimen Repository for HIV Immunopathogenesis Studies

Condition or disease
HIV-1-infection Acute HIV Infection

Detailed Description:
The goal is to build a large specimen repository for collaborating scientists to run studies of immunity and HIV-1.
Study Design
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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specimen Repository for HIV Immunopathogenesis
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
Immune Controllers
Patients with very low or undetectable levels of viremia without treatment
Acute Infection
Early infection, i.e. within 2 weeks of infection


Outcome Measures
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Primary Outcome Measures :
  1. HIV progression from acute infection to viral suppression [ Time Frame: 2 years ]
    Outcomes will depend on scientists who use the samples for further study

  2. HIV progression and control by elite and viremic suppressors [ Time Frame: 2 years ]
    Outcomes will depend on scientists who use the samples for study


Biospecimen Retention:   Samples With DNA
PBMCs and Plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Acutely HIV infected individuals HIV infected individuals who are not on anti-retrovirals and have a viral load between 50 and 3,000 HIV infected individuals who are not on anti-retrovirals and have a viral load less than 49
Criteria

Inclusion Criteria:

  1. HIV positive (acutely infected, viremic and elite controllers)
  2. Signed Informed Consent Form
  3. Age at least 18 years old
  4. Immune controllers, two types: "Elite suppressors" (HIV-positive with any three consecutive plasma HIV-1 RNA PCR undetectable while off treatment) or "viremic suppressors" (HIV-positive with any three consecutive HIV-1 RNA PCR <3000 while off treatment).
  5. Acutely infected subjects:

Persons identified to have a negative HIV antibody response (ELISA) but positive detection of HIV-1 in the blood (RT-PCR) or individuals who have evidence of a recent (past 30 days) HIV negative result along with a current HIV positive result.

Exclusion Criteria:

  1. Uncontrolled bleeding diathesis.
  2. Pregnant.
  3. Inability to provide informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579381


Locations
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United States, California
AIDS Healthcare Foundation - Public Health Division
Los Angeles, California, United States, 90027
Sponsors and Collaborators
AIDS Healthcare Foundation
University of California, Los Angeles
Investigators
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Study Director: Otto O Yang, MD Scientific Director
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: AIDS Healthcare Foundation
ClinicalTrials.gov Identifier: NCT03579381    
Other Study ID Numbers: AHF 03
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes