Human Immunodeficiency VirusNCT03205696
Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection
An observational study of Human Immunodeficiency Virus, run by University of California, Los Angeles at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Antiretrovirals
- How many people
- 101 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2017to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Los Angeles
Los Angeles, California, 90025
Los Angeles LGBT Center
Los Angeles, California, 90069
Tulane University
New Orleans, Louisiana, 70112
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Antiretrovirals
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiretroviralsDrug
Also called Genvoya, Stribild
The antiretroviral (ARV) regimen provided by the clinician must follow DHHS guidelines for antiretroviral naïve adolescents and adults
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Antiretrovirals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Evaluate HIV-1-specific CD4+ and CD8+ T-cells
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.
Measured: 12 and 24 months
Assess the amount of unspliced HIV-1 RNA
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
Measured: 12 and 24 months
Assess cell-associated HIV-1 RNA to DNA ratio
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
Measured: 12 and 24 months
Assess the decay of HIV proviral DNA
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.
Measured: 24 months
Assess the time to undetectable HIV RNA
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
Measured: 24 months
Evaluate demographic and behavioral factors associated with sustained adherence to ART
To evaluate demographic and behavioral factors associated with sustained adherence to ART or contrarily, risk of HIV transmissibility in recently infected youth.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Aug 2017
- Primary completion20 Jul 2021
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles LGBT Center, Tulane University
- Responsible party
- Principal investigator, Karin Nielsen, University of California, Los Angeles
- Investigators
- Karin Nielsen, M.D., Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205696
- Sponsor's protocol ID
- ATNAcuteInfection
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2017
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03205696
- Acronym / sponsor ID
- ATNAcuteInfection
- Conditions
- Human Immunodeficiency Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Los Angeles LGBT Center, Tulane University
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Drug: Antiretrovirals36 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 |
| Controls | – | Drug: Antiretrovirals36 youth with newly diagnosed HIV but established HIV infection (Fiebig VI) with standard care of antiretrovirals (ARV) regimen provided by the clinician |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntiretroviralsAlso: Genvoya, StribildThe antiretroviral (ARV) regimen provided by the clinician must follow DHHS guidelines for antiretroviral naïve adolescents and adults | Drug | Cases, Controls |
Primary outcome
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.
6 secondary outcomes
Evaluate HIV-1-specific CD4+ and CD8+ T-cells
Time frame: 12 and 24 months
Assess the amount of unspliced HIV-1 RNA
Time frame: 12 and 24 months
Assess cell-associated HIV-1 RNA to DNA ratio
Time frame: 12 and 24 months
Assess the decay of HIV proviral DNA
Time frame: 24 months
Assess the time to undetectable HIV RNA
Time frame: 24 months
Evaluate demographic and behavioral factors associated with sustained adherence to ART
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Nielsen, M.D. study chair
University of California, Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of cell-associated HIV-1 DNA (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.