Single cohort study of the effect of low dose naltrexone on the evolution of immunological, virological and clinical state of HIV+ adults in Mali

Abstract

To implement an immuno-regulatory approach for reducing or preventing the onset of AIDS symptoms in HIV+ 
individuals a single prospective cohort study was conducted to evaluate the effect of low-dose naltrexone (LDN) on 
HIV infected, asymptomatic, otherwise untreated Mali adults with CD4 levels between 350 and 600 cell/mm3. We 
measured changes in CD4 count, CD4%, BMI, hemoglobin, viral load, interferon alpha, and standard chemistry panel 
five times over a nine-month period. Linear regression mixed models were used with maximum likelihood as the 
estimation method for repeated measures on subjects. Of 55 subjects followed, 71% completed the full program 
without indications of clinical AIDS symptoms, side effects or enough loss of CD4 count to warrant initiation of ART 
medication. The decrease of CD4 count was marginally significant over the full testing period (p=.066) and became 
significant as the cohort aged (37.73 cells/mm3 with p=0.027 and 52.94 cells/mm3 with p=0.003, respectively, at six 
and nine months). In contrast, the estimated mean CD4% did not show significant decrease over the entire study 
(p=0.842). No other covariates were associated significantly with the results. These findings support the therapeutic 
potential of LDN in treating HIV+ in its early stages and suggest further studies are indicated.