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Clinical Trials for People with Suboptimal Immune Reconstitution Despite HIV Suppression

Last updated 3/2/2016

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 TAGline, Spring 2013). For this reason, 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 by clicking on the study title link.

Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial (LIFE-HIV)
UCSF, San Francisco, California, United States
NIH Clinical Center, Bethesda, Maryland, United States
Allina Health, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
ART for >2 years, CD4 T cell count <600, viral load <200 copies/mL

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)

Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
AIDS Clinical Trials Group - multiple sites in the United States and Puerto Rico
ART for >1 year, CD4 T cell count <350, viral load below the lower limit of detection using an FDA-approved assay 

Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
University of Minnesota, Division of Infectious Diseases, Minneapolis, Minnesota, United States
ART for >1 year, CD4 T cell count 200-600, viral load <50 copies/mL

Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients Infected Patients
University of Sao Paulo - General Hospital, São Paulo, Brazil,
On suppressive antiretroviral treatment with poor CD4+ T-cell recovery

Safety and Efficacy of Allogenic Adoptive Cell Therapy for Immune Reconstitution in Chronic HIV-1 Infected Patients
Beijing 302 Hospital, Beijing, China
ART for >2 years, CD4 T cell count <250 but >50, viral load <50 copies/mL

Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
Hospitales Universitarios Virgen del Rocío, Sevilla, Spain
Immunological discordant response defined as an increase <75 or <150 in CD4 cell counts after one or two years of undetectable viral load, respectively, or as a count of CD4 cell count <350 after 3 years of antiretroviral treatment and undetectable viraemia (<50 copies/ml) ≥ 1 year

Beijing 302 Hospital, Beijing, China and the Yunnan Hospital of Infectious Diseases, Kunming, Yunnan, China
Study of a Chinese herb, Triptolide Woldifii
ART for >2 years, CD4 T cell count <250, viral load <400 copies/mL
Umbilical Cord Mesenchymal Stem Cells for Immune Reconstitution in HIV-infected Patients
China, Beijing 302 Hospital
A study investigating whether mesenchymal stem cells (MSC) can suppress inflammation and restore CD4 T cell counts in individuals with suppressed HIV viral load and CD4 counts less than 250
Encouraging results from early phase trial now published