Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03205696 |
Other study ID # |
ATNAcuteInfection |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2017 |
Est. completion date |
November 30, 2022 |
Study information
Verified date |
October 2022 |
Source |
University of California, Los Angeles |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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 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.
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.