Specimen Repository for HIV Immunopathogenesis

Specimen Repository for HIV Immunopathogenesis Studies

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • AIDS Healthcare Foundation - Public Health Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV progression from acute infection to viral suppression	Outcomes will depend on scientists who use the samples for further study	2 years
HIV progression and control by elite and viremic suppressors	Outcomes will depend on scientists who use the samples for study	2 years

Collaborators and Investigators

• Sponsor: AIDS Healthcare Foundation
• Collaborators: University of California, Los Angeles
• Investigators: Study Director: Otto O Yang, MD, Scientific Director

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2017
• Primary Completion (ACTUAL): January 25, 2019
• Study Completion (ACTUAL): January 25, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: AHF 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No