title: Evaluation of the antiretroviral activity of a new polyherbal drug (Immu-25) in patients with HIV infection.
abstract: OBJECTIVE
  To evaluate the clinical efficacy and safety of a new polyherbal preparation, Immu-25, in HIV-infected patients.
  
  
  METHODS
  36 patients (10 female, 26 male) with a mean age of 35 +/-10 years, with confirmed HIV infection with a CD4 count <500 cells/microL, received two capsules of the test drug twice daily for 18 months in this open-label pilot study. Patients were evaluated at monthly intervals for general signs and symptoms, development of opportunistic infections, and changes in weight and performance index. Lymphocyte phenotyping and routine haematological, biochemical, hepatic and renal parameters were recorded after every 6 months of drug therapy. Viral load was evaluated before and after every 6 months of treatment.
  
  
  RESULTS
  The polyherbal test preparation produced good symptomatic improvement within 6 months. There was an increase in mean (95% CI) weight from 58 (53-64)kg to 63 (56-69)kg, 64 (58-72)kg and 68 (62-74)kg after 6, 12 and 18 months of treatment, respectively. The incidence and severity of symptoms such as diarrhoea, fatigue, anorexia, cough and fever decreased with drug treatment. There was a decrease in the mean (95% CI) viral load from 326 438 (428 600-186 420) copies/mL to 180 495 (258 300-124 000) copies/mL and 22 069 (42 100-16 000) copies/mL after 6 and 12 months of treatment, respectively. The decrease in viral load was associated with an increase in mean (95% CI) CD4 count from a baseline of 243 (203-388) cells/microL to 336 (263-486) cells/microL after 6 months of therapy, and this continued to rise to 527 (285-767) cells/microL (p < 0.001) and 618 (362-1012) cells/microL (p < 0.001) after 12 and 18 months of treatment, respectively. With the exception of mild gastrointestinal adverse effects, the drug was well tolerated. Both patients and investigators rated the treatment as good or very good.
  
  
  CONCLUSIONS
  The polyherbal drug Immu-25 showed a favourable effect in patients with HIV infection. The test drug decreased the mean viral load, which was associated with good symptomatic improvement and an increase in the mean CD4 cell count. On the basis of these data, it can be concluded that this herbal drug may have a good immunomodulatory effect and has potential as a co-therapeutic agent in the management of HIV infection. Further studies are warranted to confirm its therapeutic potential.
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India. ushapingali@yahoo.com
authors.forename: P R
authors.initials: PR
authors.lastname: Usha
authors.forename: M U R
authors.initials: MU
authors.lastname: Naidu
authors.forename: Y S N
authors.initials: YS
authors.lastname: Raju
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D015704:CD4 Antigens / Q000097:blood; D016827:CD8 Antigens / Q000097:blood; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D031339:Ocimum; D010361:Patients; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D013997:Time Factors; D031610:Tinospora; D016896:Treatment Outcome; D019562:Viral Load / Q000379:methods*; D032341:Withania
chemical_list: D019380:Anti-HIV Agents; D015704:CD4 Antigens; D016827:CD8 Antigens; C478628:Immu-25; D010936:Plant Extracts