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

March 24, 2025 updated by: Karin Nielsen, University of California, Los Angeles

A Comprehensive Community-Based Strategy to Optimize the HIV Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adolescents who are displaced and living in shelters or in the streets constitute an extremely vulnerable population for acquisition of HIV infection worldwide. In the U.S., homeless youth, particularly African American Gay, Bisexual, and Transgendered Youth (GBTY), are very susceptible to substance abuse, juvenile justice contact, and acquisition of HIV and other sexually transmitted infections (STI). The displaced adolescent population is not generally amenable to routine clinic follow-up in hospital settings and potentially more easily identified through mobile outreach efforts. HIV prevalence in this group can be as high as 5.3%. While HIV incidence is unknown, high rates of concurrent exposures to other STIs, substance abuse, and survival sex suggest acute infection is likely high. Pediatric studies of HIV perinatally infected infants treated very early with potent antiretroviral therapy as well as studies of adult cohorts treated during acute infection, have shown that very early treatment of HIV is associated with control and decrease in viral reservoir burden, which is likely predictive of long term HIV control. Although early treatment has not yet been demonstrated to induce a functional cure, it has been associated with an extended period of complete viral quiescence, also known as HIV drug free remission. No studies of this kind have enrolled significant numbers of adolescents. Some studies suggest HIV reservoirs from adolescents who were recently HIV infected may be more pliable and responsive to early combined antiretroviral treatment (cART) than that of adults. Prolonged control of HIV through cART initiated following established HIV infection does not appear to impact viral reservoir size. HIV remission is not attainable in this scenario following treatment interruption, even after many years of undetectable plasma virus levels while on cART. We hypothesize that very early antiretroviral treatment of adolescents with acute HIV infection will be associated with decreased viral reservoir size, and viral reservoir size will be significantly different between adolescents with acute, recent or established HIV infection. To evaluate our hypothesis, we propose to capitalize on a current community-based strategy to initiate very prompt antiretroviral treatment many times the very day of diagnosis of HIV infection. Patients with newly diagnosed HIV infection will be offered antiretroviral treatment immediately or within a very short time by our collaborating clinical sites, and through the present study will be monitored periodically for assessment of virus load and HIV reservoir assays.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • University of California, Los Angeles
      • Los Angeles, California, United States, 90069
        • Los Angeles LGBT Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  1. Male or female participants age 12 to 24 years.
  2. 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.
  3. Ability and willingness to provide written informed consent.
  4. Willingness to initiate ART
  5. Willingness of treating clinician to follow DHHS guidelines for antiretroviral naïve adolescents and adults

Exclusion Criteria:

  1. Prior ART use.
  2. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  3. 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.
  4. Chronic or recurrent use of medications that modify host immune response, e.g., oral or parenteral steroids, cancer chemotherapy.
  5. Clinical treatment with an ARV regimen less effective than those recommended by DHHS HIV clinical guidelines.
  6. Enrollment on a experimental ARV regimen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
The antiretroviral (ARV) regimen provided by the clinician must follow DHHS guidelines for antiretroviral naïve adolescents and adults
Other Names:
  • Genvoya
  • Stribild
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
The antiretroviral (ARV) regimen provided by the clinician must follow DHHS guidelines for antiretroviral naïve adolescents and adults
Other Names:
  • Genvoya
  • Stribild

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amount of cell-associated HIV-1 DNA
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate HIV-1-specific CD4+ and CD8+ T-cells
Time Frame: 12 and 24 months
To evaluate HIV-1-specific CD4+ and CD8+ T-cells by flow cytometry prior to ART initiation and while HIV-1 RNA is suppressed on ART at 12 and24 months.
12 and 24 months
Assess the amount of unspliced HIV-1 RNA
Time Frame: 12 and 24 months
To assess the amount of unspliced HIV-1 RNA in 5 million blood-derived CD4+ T- cells prior to ART initiation and while HIV-1 RNA is suppressed on ART at 12, and 24 months
12 and 24 months
Assess cell-associated HIV-1 RNA to DNA ratio
Time Frame: 12 and 24 months
To assess cell-associated HIV-1 RNA to DNA ratio in participants with quantifiable HIV-1 DNA prior to ART initiation and while HIV-1 RNA is suppressed on ART at 12, and 24 months
12 and 24 months
Assess the decay of HIV proviral DNA
Time Frame: 24 months
To assess the decay of HIV proviral DNA by ddPCR over the observational period up to 24 months in youth with acute vs established infection.
24 months
Assess the time to undetectable HIV RNA
Time Frame: 24 months
To assess the time to undetectable HIV RNA among the acute and established youth and the subsequent HIV DNA decay and HIV immune parameters over the observational period up to 24 months
24 months
Evaluate demographic and behavioral factors associated with sustained adherence to ART
Time Frame: 24 months
To evaluate demographic and behavioral factors associated with sustained adherence to ART or contrarily, risk of HIV transmissibility in recently infected youth.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tulane University
Los Angeles LGBT Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Karin Nielsen, M.D., University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATNAcuteInfection

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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