Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection

NCT03205696 | Completed

• 1 other identifier: ATNAcuteInfection
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 3

Brief Summary

This is a strategic prospective cohort study which will measure the effects of early intensive antiretroviral therapy (ART) on the establishment and persistence of HIV-1 reservoirs and HIV-1-specific immunity in acutely /recently HIV infected youth aged 12 to 24 years as compared to newly diagnosed youth with established infection \> 6 months. Participants with newly diagnosed acute /recent HIV-1 infection will be offered enrollment into the study with immediate initiation of ART which is the current standard of care.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Amount of cell-associated HIV-1 DNA

  To compare the amount of cell-associated HIV-1 DNA (CAHD) in 5 million blood-derived CD4+ T-cells and total PBMC (assayed by quantitative ddPCR \[qPCR\]) at 12 months in participants who initiated ART in Fiebig I/II versus Fiebig III/IV versus Fiebig V and those with newly diagnosed but established/chronic HIV infection with sustained suppression of plasma HIV-1 RNA.

  12 months

Secondary Outcomes (6)

• Evaluate HIV-1-specific CD4+ and CD8+ T-cells

  12 and 24 months

• Assess the amount of unspliced HIV-1 RNA

  12 and 24 months

• Assess cell-associated HIV-1 RNA to DNA ratio

  12 and 24 months

• Assess the decay of HIV proviral DNA

  24 months

• Assess the time to undetectable HIV RNA

  24 months

Study Arms (2)

Cases

36 youth with new diagnosis of acute/recent HIV as defined by laboratory assays Fiebig1-V with standard care of antiretrovirals (ARV) regimen provided by the clinician

Drug: Antiretrovirals

Controls

36 youth with newly diagnosed HIV but established HIV infection (Fiebig VI) with standard care of antiretrovirals (ARV) regimen provided by the clinician

Drug: Antiretrovirals

Interventions

Antiretrovirals DRUG

The antiretroviral (ARV) regimen provided by the clinician must follow DHHS guidelines for antiretroviral naïve adolescents and adults

Also known as: Genvoya, Stribild

Cases; Controls

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Our study will be recruiting youth between the ages of 12 and 24 years with newly diagnosed HIV infection (Acute /Recent or Established HIV). The study is open to all patients within this age group with a new diagnosis of HIV infection, including pregnant women. This study will include adolescents who are displaced and living in shelters or in the streets. These homeless youth will include African American Gay, Bisexual, and Transgendered Youth (GBTY), who are very susceptible to substance abuse, juvenile justice contact, and acquisition of HIV and other sexually transmitted infections (STI).

You may qualify if:

• Male or female participants age 12 to 24 years.
• A positive HIV diagnostic assay following a negative HIV diagnostic assay obtained in the previous study visit (if subjects are enrolled in the high risk cohort study- Project 3) or within the last six months if not followed in Study 3. A positive HIV test at baseline for subjects who are included as part of the recently diagnosed arm. HIV diagnostic assays include POC rapid tests including 4th generation rapid assays, GeneXpert HIV qualitative assays, HIV antibody assays, and HIV RNA or DNA PCR assays.
• Ability and willingness to provide written informed consent.
• Willingness to initiate ART
• Willingness of treating clinician to follow DHHS guidelines for antiretroviral naïve adolescents and adults

You may not qualify if:

• Prior ART use.
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant.
• Chronic or recurrent use of medications that modify host immune response, e.g., oral or parenteral steroids, cancer chemotherapy.
• Clinical treatment with an ARV regimen less effective than those recommended by DHHS HIV clinical guidelines.
• Enrollment on a experimental ARV regimen

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Los Angeles LGBT Center: collaborator
• Tulane University: collaborator

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90025, United States

Location

Los Angeles LGBT Center

Los Angeles, California, 90069, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Study site staff will store blood specimens collected in this study at least through the end of the study. In addition, as part of the informed consent process, subjects will be asked to provide written informed consent for blood specimens to be stored after the end of the study for possible future testing. The specimens of participants who do not consent to long-term storage and additional testing will be destroyed at the end of the study

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Anti-Retroviral Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Karin Nielsen, M.D.

  University of California, Los Angeles

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: July 20, 2021
• Study Completion: November 30, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)