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Last updated 12/16/2019

Some individuals who initiate antiretroviral therapy (ART) experience limited recovery of CD4 T cell numbers despite suppression of HIV viral load to undetectable levels. The most common risk factors for this type of discordant response to ART are low CD4 T cell count at the time of starting and older age. Individuals in this situation still experience a benefit from ART in terms of a greatly reduced risk of opportunistic infections, illness and death, but their risk of these outcomes is higher than among people with greater CD4 T cell gains (for additional background see the webinar hosted by TAG on November 29, 2017 and our March 2018 Issue Brief).

A number of clinical trials are investigating approaches that might boost CD4 T cell recovery in individuals whose CD4 T cell counts remain relatively low despite viral load suppression. The purpose of this page is to provide a resource listing of these clinical trials, which will be updated on an ongoing basis.

Complete information on the trials is available from clinicaltrials.gov by clicking on the study title link.

A Single Dose of Pembrolizumab in HIV-Infected People
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
ART for >/= 12 months, CD4 cell count 100-350, viral load <40 copies/mL for >/= 12 month (single blip >40 copies/mL but <500 copies/mL allowed)

Rice Bran Supplementation in Treated HIV Infection (BRM4) (closed to enrollment)
Rand Schrader Health and Research Clinic, Los Angeles, California, United States
ART for >24 weeks, CD4 cell count 100-350, viral load <50 copies/mL

Pyridostigmine as Immunomodulator in People Living With HIV (closed to enrollment)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Tlalpan, Ciudad de México, Mexico
Stable ART for at least six months, at least two undetectable viral load determinations in the previous six months

Probiotic VSL#3 for Inflammation and Translocation in HIV II (PROOV IT II)
Maple Leaf Medical Clinic & Toronto General Hospital, Toronto, Ontario, Canada
ART for >2 years, CD4 T cell count <350 for last 2 years, viral load <50 copies/mL for the past 2 years (1 viral blip over 500 copies/ml permitted in the past year)

Blood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Observational study including a cohort with CD4 T cell count <300 cells after 2 years of effective combination ART with documentation of viral suppression

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