AEGiS-15IAC: Efficacy and safety of Zidovudine and Zalcitabine combined with combination of herbs in the treatment of HIV-infected Thai patients.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Efficacy and safety of Zidovudine and Zalcitabine combined with combination of herbs in the treatment of HIV-infected Thai patients.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. B10233)

Sangkitporn DR, Shide DR, Klinbuayaem DR, Leenasirimakul DR, Wirayutwatthana DR, Leechanachai DR, Dettrairat MR, Kunachiwa DR, Thamlikitkul DR
Department of medical sciences, Nonthaburi, Thailand

BACKGROUND: One of the herbal candidates in the joint research and development between Department of Medical Sciences, Thailand and Kunming Institute of Botany, China is a herbal formulation containing 5 herbs (SH) which has been widely used in China. It was found that each herb and combined SH herbs had anti-retroviral activity. The phase I/II clinical trial of SH herbs in 28 asymptomatic HIV-infected patients revealed that 43% had decreased HIV RNA greater than 0.5 log after receiving SH herbs for 3 months. The objective of this study was to determine the efficacy and safety of SH herbs as adjunctive therapy with two nucleoside reverse transcriptase inhibitors in a randomized double blind placebo controlled fashion.

METHODS: The study was conducted in 5 hospitals in Thailand. The subjects were Thai adults with HIV-1 infection. The subjects received a combination of ZDV 200 mg. three times per day, ddC 0.75 mg. three times per day, and SH herbs 2.5 grams three times per day or a combination of ZDV 200 mg. three times per day, ddC 0.75 mg. three times per day, and placebo 2.5 grams three times per day for 24 weeks. The primary efficacy outcome was a reduction of plasma HIV RNA and the secondary efficacy outcome was a change in the CD4 cells from baseline.

RESULTS: The baseline characteristics of 60 evaluable subjects, 40 in the SH group and 20 in the placebo group, were not significantly different. HIV RNA at week 4 and thereafter was significantly decreased from the baseline value in both groups (p<0.001). However, the decline in HIV RNA in the SH group was significantly more than that in the placebo group. The CD4 cells in the SH group at week 12 and thereafter were significantly increased from the baseline value. Serious adverse events in the two groups were not observed.

CONCLUSION: The addition of SH herbs to two nucleoside reverse transcriptase inhibitors has greater antiviral activity than anti-retrovirals only.

Keywords: AEGIS, Zidovudine, HIV Infections, Zalcitabine, Acquired Immunodeficiency Syndrome, HIV Seropositivity, Disease Progression, Antiviral Agents, Thailand, China, Adult, Humans

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