African Journal of AIDS and HIV Research

African Journal of AIDS and HIV Research ISSN 2326-2691 Vol. 7 (1), pp. 001-010, January, 2019. © International Scholars Journals

Full Length Research Paper

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

Abdel K. TRAORE^1,2, Oumar THIERO^4,7*, Sounkalo DAO³, Fadia F. C. KOUNDE³, Ousmane FAYE¹, Mamadou CISSE⁶, Jaquelyn B. McCANDLESS^8*, Jack M. ZIMMERMAN⁸, Karim COULIBALY¹, Ayouba DIARRA⁴, Mamadou S. KEITA¹, Souleymane DIALLO³, Ibrahima G. Traore⁴ and Ousmane KOITA^4,5

¹Centre National d’Appui à la lutte contre la Maladie (CNAM), Bamako, Mali.

²Hôpital National du Point G (HNPG), Service de Médecine Interne, Bamako, Mali.

³Hôpital National du Point G (HNPG), Service de Maladies Infectieuses, Service de Pneumo-phtisiologie, Bamako, Mali.

⁴Laboratoire de Biologie Moléculaire Appliquée (LBMA), Mali.

⁵Faculté des Sciences et Techniques (FAST), Université de Bamako, Bamako, Mali.

⁶Centre de soins, d’animation et de conseil pour les PVVIH (CESAC).

⁷Faculty of Medicine, Pharmacy and Otondo- Stomatology (FMPOS), Department of Research in Public Health

(DER SP), University of Bamako, Bamako, Mali.

⁸The Ojai Foundation, California, USA.

Accepted 29 August, 2011

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.

Key words: HIV+, LDN, CD4-count, CD4%, immuno-enhancement, ART.