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LDN - HIV and AIDS

http://clinicaltrials.gov/show/NCT01174914

Background. Planning for this work dates back to 2003. With neurologist Dr. Jaquelyn McCandless and her colleague husband, Jack Zimmerman, as both “Expatriate Clinical Monitors” and major financial supporters, the support of Hussein Alfa Nafo, and with a local research team led by Dr. Abdel Kader Traore and other health officials at the University Hospital in Bamako, Mali in Africa, two separate studies of LDN use in HIV/AIDS have now been completed and published in a peer reviewed journal, the Journal of AIDS and HIV Research. 

The studies were approved for only a 3mg LDN dosage (rather than an anticipated 4.5mg). In addition, careful attention was given to special counseling aimed at improving preventive health practices of local women and children. Skip’s Pharmacy of Boca Raton, Florida prepared the LDN and placebo capsules. 

Summary. With the first study, the researchers found that LDN is both safe and free of side effects and that it appears to be efficacious in strengthening the immune system of HIV+ individuals. In this study’s patients, who all had HIV infection but whose CD4 levels were not yet low enough to warrant antiretroviral (ARV) drug therapy, the mean CD4 % count remained unchanged throughout the study. This is in contrast to the usual outcomes in all other similar groups in the past, who were untreated, whose CD4% continued to decline month after month inexorably. The researchers concluded that for HIV+ individuals “LDN might offer a simple, relatively safe, inexpensive and easily monitored treatment alternative.” 

The second study, a randomized clinical trial of patients with markedly reduced CD4 levels, compared those who were given both ARV and LDN to a control group given ARV and placebo. It was found that the ARV+LDN group showed a significantly higher increase in CD4 count by 6 months of treatment and it was concluded that “further exploration of LDN as part of an HIV+ treatment regimen is warranted.”

Abstracts 

1) Journal of AIDS and HIV Research Vol. 3(10), pp. 180-188, October 2011 

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

Abdel K. TRAORE, Oumar THIERO, Sounkalo DAO, Fadia F. C. KOUNDE, Ousmane FAYE, Mamadou CISSE, Jaquelyn B. McCANDLESS, Jack M. ZIMMERMAN, Karim COULIBALY, Ayouba DIARRA, Mamadou S. KEITA, Souleymane DIALLO, Ibrahima G. TRAORE and Ousmane KOITA 

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. 

2) Journal of AIDS and HIV Research Vol. 3(10), pp. 189-198, October 2011 

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

Abdel K. TRAORE, Oumar THIERO, Sounkalo DAO, Fadia F. C. KOUNDE, Ousmane FAYE, Mamadou CISSE, Jaquelyn B. McCANDLESS, Jack M. ZIMMERMAN, Karim COULIBALY, Ayouba DIARRA, Mamadou S. KEITA, Souleymane DIALLO, Ibrahima G. TRAORE and Ousmane KOITA 

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 antiretroviral (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. 

[Editor’s Note: These long awaited scientific studies on Low Dose Naltrexone for HIV+ individuals not only have helped bring the late Dr. Bihari’s dream of a Developing Nations Project much closer to realization but also have clearly demonstrated LDN’s unique ability to strengthen the immune system. If responsible health care authorities around the globe pay proper attention to these findings, it is still possible to prevent the further deterioration of tens of millions of people who are presently HIV+.]

Bihari B., Efficacy of low dose naltrexone as an immune stabilizing agent for the treatment of HIV/AIDS., AIDS Patient Care. 1995 Feb;9(1):3,

https://www.ncbi.nlm.nih.gov/pubmed/11361353

Schulhafer EP1, Verma RS. , Acquired immunodeficiency syndrome: molecular biology and its therapeutic intervention (review)., In Vivo, 1989 Mar-Apr;3(2):61-78., https://www.ncbi.nlm.nih.gov/pubmed/2519841

Abstract

AIDS is one of the most perplexing diseases to confront modern medicine today. AIDS will rank just behind accidents, heart disease and cancer as a major cause of potential life lost in the USA by 1991. Over half million AIDS cases are predicted by 1993 in the United States alone. There has been a great improvement in the understanding and treatment of opportunistic infections in AIDS. The most important concept is prophylactic treatment of the most common infectious complications as the immune system deteriorates. The major advance has been the prophylactic treatment of Pneumocystic Carinii Pneumonia (PCP) with either aerosolized Pentamidine or low dose Bactrim. Some experts advocate a low dose antibiotic prophylaxis for latent toxoplasma and cryptococcal infection in those patients whose immune systems are deteriorating. Prophylaxis would be instituted as the T4 helper lymphocyte count decreases. Finally, any patient found to be lately infected with either tuberculosis or syphilis, while HIV positive, must be thoroughly treated for these infections prior to any immunocompromise. The minimum follow-up of HIV positive individuals should include T4 lymphocyte counts and perhaps P24 antigen levels as well as beta 2-microglobulin levels. As these parameters worsen, patients should be directed to explore safe available treatments such as Antabuse, Naltrexone and Dextran sulfate. Any healthy patient with T4 helper counts under 400 should be directed to AIDS treatment evaluation units for enrolment in research protocols. At present over 100 drugs are being tested for the treatment of AIDS. However, researchers predict that no more than one or two drugs will be discovered over the next three years that will be helpful in the treatment of AIDS. If ever there was a more powerful argument to institute a new way of evaluating research drugs, it is this prediction. Due to the epidemic proportions of this disease, it seems reasonable to test epidemic proportions of this disease, it seems reasonable to test drugs shown to have some effect in groups of three of four drugs per patient. It is well demonstrated that AZT (Zidovudine) loses its anti-retroviral effect at about twelve to eighteen months. Drug resistance is seen in the treatment of a similar infectious agent, M. tuberculosis. Acute infection of MTB necessitates the use of three antibacterial agents. In AIDS infection, it seems logical to test two or three anti-retrovirals combined with one immunostimulant.(ABSTRACT TRUNCATED AT 400 WORDS)

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