An observational study in Human Immunodeficiency Virus, sponsored by University of California, Los Angeles. Completed at 3 sites in United States. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by University of California, Los Angeles · Observational
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 101 is below the median of 200 across 713 observational studies indexed under HIV Infections.
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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).
Exclusion Criteria:
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
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
Also known as: Genvoya, Stribild
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.
Time frame: 12 months
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 24 months
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles