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Specimen Repository for HIV Immunopathogenesis

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ClinicalTrials.gov Identifier: NCT03579381
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
HIV Immunotheraupeutics Institute
Information provided by (Responsible Party):
AIDS Healthcare Foundation

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specimen Repository for HIV Immunopathogenesis
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



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


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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.

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


Contacts
Contact: Leonardo Colemon, MA 323-498-6680 leonardo.colemon@aidshealth.org
Contact: Adam C Cohen, Phd 323-436-8926 adam.cohen@aidshealth.org

Locations
United States, California
AIDS Healthcare Foundation - Public Health Division Recruiting
Los Angeles, California, United States, 90027
Contact: Sagar Amin, BA    323-836-4900    sagar.amin@aidshealth.org   
Sponsors and Collaborators
AIDS Healthcare Foundation
University of California, Los Angeles
HIV Immunotheraupeutics Institute
Investigators
Study Director: Otto Yang, MD Scientific Director

Responsible Party: AIDS Healthcare Foundation
ClinicalTrials.gov Identifier: NCT03579381     History of Changes
Other Study ID Numbers: AHF 03
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases