Impact of low dose naltrexone (LDN) on antiretroviral therapy (ART) treated HIV+ adults in Mali: A single blind randomized clinical trial

Abstract

To implement an immuno-regulatory approach for reducing or preventing the onset of AIDS symptoms in HIV+ 
individuals we conducted a single blind nine-month randomized clinical trial to evaluate the impact of low-dose 
naltrexone (LDN) on asymptomatic HIV+ Mali adults undergoing antiretro virial (ART) treatment with CD4 counts 
below 350 cell/mm3 . We measured differences between groups in CD4 count, CD4%, hemoglobin, viral load, 
interferon alpha, and standard chemistry panel five times during the clinical period. The random mixed model 
and restricted maximum likelihood method for estimating slopes for repeated measures on subjects were used 
to predict CD4 counts and CD4%. The improvement in CD4 count in the treatment group (51 subjects) was 
significantly greater than the control group (49 subjects) at 6 months (p = 0.041) and marginally at 9 months (p = 
0.067). Improvement in CD4% in the treatment group also was observed throughout the clinical period but these 
increases were not significant relative to the control group. Since, for this period of time, the combination of LDN ART appears to be more effective in increasing CD4 count, and since LDN is inexpensive, easy to 
administer and without side effects, further exploration of LDN together with ARV treatment is recommended.