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

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ClinicalTrials.gov Identifier: NCT03205696
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
Los Angeles LGBT Center
Tulane University
Information provided by (Responsible Party):
Karin Nielsen, University of California, Los Angeles

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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Drug: Antiretrovirals

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.

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205696


Contacts
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Contact: Karin Nielsen, M.D. 310-825-5235 knielsen@mednet.ucla.edu
Contact: Yvonne Bryson, M.D. 310-825-5235 ybryson@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90025
Contact: Kate Mitchell, B.A.    310-203-5262    kmitchell@mednet.ucla.edu   
Los Angeles LGBT Center Recruiting
Los Angeles, California, United States, 90069
Contact: Robert Bolan, M.D.    323-993-7500    bbolan@lalgbtcenter.org   
United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sue E Abdalian, M.D.    504-988-5348    sabdali@tulane.edu   
Contact: Leslie Kozina, R.N.    504-988-5348    lkozina@tulane.edu   
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles LGBT Center
Tulane University
Investigators
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Study Chair: Karin Nielsen, M.D. University of California, Los Angeles
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Responsible Party: Karin Nielsen, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03205696    
Other Study ID Numbers: ATNAcuteInfection
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Genvoya
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents