Specimen Repository for HIV Immunopathogenesis

NCT03579381 | Completed

• 1 other identifier: AHF 03
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Specimen Repository for HIV Immunopathogenesis Studies

Conditions

HIV-1-infection; Acute HIV Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Immune Controllers

Patients with very low or undetectable levels of viremia without treatment

Acute Infection

Early infection, i.e. within 2 weeks of infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• HIV positive (acutely infected, viremic and elite controllers)
• Signed Informed Consent Form
• Age at least 18 years old
• 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).
• 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.

You may not qualify if:

• Uncontrolled bleeding diathesis.
• Pregnant.
• Inability to provide informed consent.

Sponsors & Collaborators

• AIDS Healthcare Foundation: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

AIDS Healthcare Foundation - Public Health Division

Los Angeles, California, 90027, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

PBMCs and Plasma

Study Officials

• Otto O Yang, MD

  Scientific Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: July 6, 2018
• Study Start: July 31, 2017
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)