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Phase I/II randomized, open-label study of oral curcumin safety, and antiviral effects on HIV-RT PCR in HIV+ individuals.

Hellinger JA, Cohen CJ, Dugan ME, Day JM, Cavanaugh JF, Glidden D; Conference on Retroviruses and Opportunistic Infections.

Program Abstr 3rd Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 3rd 1996 Wash D C. 1996 Jan 28-Feb 1; 3rd: 78.

CRI of New England, Harvard School of Public Health, Boston, MA.

Curcumin, an anti-oxidant component of the food spice tumeric, at non-cytotoxic levels, inhibits TNF-alpha stimulation of HIV-LTR in a variety of cell lines. OBJECTIVE: To evaluate the safety and antiviral effects in HIV+ individuals. METHODS: Following blocked, stratified randomization to 1) high dose (4800mg./day=4 capsules QID) or lower dose (2700 mg./day=3 capsules TID) and 2) immediate or 8 week delayed initiation, we gave oral curcumin to HIV+ persons for 8 weeks. Baseline and serial testing included physical examination, safety labs (hematology, chemistries, urinalysis) CD4/8+ counts and HIV-RNA RT-PCR (Roche Labs). All participants had at least two HIV-RNA measures obtained prior to study drug, and participants assigned to delayed drug initiation had 3 values. Curcumin was provided as Turmeric Power, Natures Herbs, Orem, UT. RESULTS: Of the 40 HIV+ persons (8 women, 32 men) enrolled, 2 were unable to complete the study due to adverse events unrelated to study drug. The median baseline values for all patients is 47,010 copy/ml (range 440-1,067,720 copies/ml), with slightly higher values in persons randomized to low dose. Average log 10 copy number (HIV-RNA RT-PCR). (table: see text). Overall, neither high low dose curcumin appears to significantly decrease HIV-RNA copy number, or to change CD4+ cell counts. A mixed effects model was fit which included main effects for treatment, drug week, immediate\delay, with a treatment by week interaction. This model found that the dosing group had no effect on RNA copy number (X(2)df 3,= 2.41, p= 0.49), or CD4+ lymphocytes (X(2)df3,=3.54, p=0.32). Steady state drug level testing is pending.

Publication Types:
  • Meeting Abstracts
Keywords:
  • AIDS Vaccines
  • Acquired Immunodeficiency Syndrome
  • Antiviral Agents
  • Biomedical Research
  • CD4 Lymphocyte Count
  • Curcumin
  • Female
  • HIV Infections
  • HIV Seropositivity
  • Humans
  • Male
  • Reverse Transcriptase Polymerase Chain Reaction
  • Safety
Other ID:
  • 96920140
UI: 102216191

From Meeting Abstracts




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