Evident stabilization of the clinical profile in HIV/AIDS as evaluated in an open label clinical trial using a polyherbal formulation
Mangaiarkarasi Asokan1, Imtiaz Nisar Lone1, Anil Babu Mukthey1, Paul Siddhartha1, Gayathri Mariappa2, Praveen Kumar Kotehal2, Bhuthiah Satish2, Eugene Wilson3, Savariraj Sahayam3, Gopinath Velayutham3, Rajalakshmi Perumal3, Karthikeyan Baskaran3, Devanathan Rengarajan3, Ravichandran Muthusamy3, Mariamma Philip4, KC Ravindra5, Jeelan N Basha5, Pushpak Mizar5, Gurvinder Kaur6, Narinder K Mehra6, Tapas K Kundu5, DK Subbakrishna4, Kadappa Shivappa Satish2, Udaykumar Ranga1
1 HIV-AIDS Laboratory, Molecular Biology & Genetics Unit, Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore, India
2 Seva Free Clinic & Chest & Maternity Centre, Bangalore, India
3 Shanmugha Arts, Science, Technology and Research Academy, Thanjavur, India
4 Department of Biostatistics, National Institute of Mental Health & Neuro Sciences, Bangalore, India
5 Transcription & Disease Laboratory, Molecular Biology & Genetics Unit, Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore, India
6 Department of Transplant Immunology & Immunogenetics, All India Institute of Medical Sciences, New Delhi, India
Professor, HIV-AIDS Laboratory, Molecular Biology & Genetics Unit, Jawaharlal Nehru Centre for Advanced Scientific Research Jakkur (PO), Bangalore 560 064
Source of Support: None, Conflict of Interest: None
Background & objectives: The complementary and alternative medicines (CAM) have not been systematically evaluated for the management of HIV/AIDS patients. In a prospective, single-site, open-label, non-randomized, controlled, pilot trial, we evaluated a polyherbal formulation (PHF) for its safety and efficacy in treating subjects with HIV-AIDS.
Methods: A total of 32 and 31 subjects were enrolled under the PHF and highly active antiretroviral treatment (HAART) arms, respectively, and followed up for a period of 24 months. Plasma viral RNA, CD4 cell count and blood chemistry were monitored at 3-month intervals. Following mid-term safety evaluation, 12 subjects from the PHF arm were shifted to HAART and were followed separately as PHF-to-HAART arm, for the rest of the period.
Results: The HAART arm was characterized by significant improvements in CD4 cell count (154.4 cells/μl/year, P<0.001) and reduction in plasma viral load within 3 to 6 months (-0.431+ 0.004 log 10 IU/month, P<0.001). In contrast, the PHF arm showed a profile of CD4 cell loss at remarkably slower kinetics (14.3 cells/μl/year, P=0.021) and insignificant reduction in the viral load. The PHF and HAART arms did not differ significantly in the occurrence of AIDS-related illnesses over the study period of 24 months. In the PHF-to-HAART arm, the rates of CD4 count and reduction in viral load were significant and comparable to that of the HAART group. In the PHF arm, at 1 month, a significant increase in CD4 cell count and a concomitant decrease in viral load were seen.
Interpretation & conclusions: The PHF appears to have provided protection by delaying the kinetics of CD4 cell reduction. Given the several study limitations, drawing assertive inferences from the data is challenging. Future studies with a stringent study design are warranted to confirm these findings.