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ORIGINAL ARTICLE
Year : 2015  |  Volume : 9  |  Issue : 1  |  Page : 25-33

Clinical trial for evaluation of a Human Immunodeficiency Virus nosode in the treatment for Human Immunodeficiency Virus-Infected individuals


Director & Head, Research & Development, Mumbai, Maharashtra, India

Correspondence Address:
Rajesh Shah
Life Force, 411 Krushal Commercial Complex, GM Rd, Chembur, Mumbai ? 400 089, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7168.154345

Clinical trial registration CTRI/2011/12/002228

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Introduction: Identifying the need for strengthening of the immune system, the investigator has developed new Human Immunodeficiency Virus (HIV) nosode and evaluated its effect on HIV positive individuals through a clinical trial. Methods: Standardized and the scientific method of HIV nosode preparation has been described and documented. Thirty-seven HIV-infected persons were registered for the trial, and ten participants were dropped out from the study, so the effect of HIV nosode 30C and 50C, was concluded on 27 participants under the trial. Results: Out of 27 participants, 7 (25.93%) showed a sustained reduction in the viral load from 12 to 24 weeks. Similarly 9 participants (33.33%) showed an increase in the CD4+ count by 20% altogether in 12 th and 24 th week. Significant weight gain was observed at week 12 (P = 0.0206). 63% and 55% showed an overall increase in either appetite or weight. The viral load increased from baseline to 24 week through 12 week in which the increase was not statistically significant (P > 0.05). 52% (14 of 27) participants have shown either stability or improvement in CD4% at the end of 24 weeks, of which 37% participants have shown improvement (1.54-48.35%) in CD4+ count and 15% had stable CD4+ percentage count until week 24 week. 16 out of 27 participants had a decrease (1.8-46.43%) in CD8 count. None of the adverse events led to discontinuation of study. Conclusion: The study results revealed improvement in immunological parameters, treatment satisfaction, reported by an increase in weight, relief in symptoms, and an improvement in health status, which opens up possibilities for future studies.


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