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Chinese herbal formula study report (ABSTRACT)—
XQ-9302
Report on a Phase I/II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, and Effects on Quality-of-Life, of XQ-9302, a Compound Comprised of Twenty (20) Chinese Botanicals, in HIV-1 Infected Individuals

XQ-9302, an herbal medicine consisting of 20 plants, has previously been shown to exert anti-HIV activity in cell culture experiments. Mean viral load in a group of 5 HIV-positive patients in a limited, open-label clinical trial in China fell by 1.3 log following XQ-9302 treatment as monotherapy. In this 8-week, randomized, double-blind, placebo-controlled study, XQ-9302 (6 capsules every 6 hours) was evaluated for its ability to enhance quality of life, and secondarily for anti-HIV activity and immunological improvement, in HIV-positive subjects.

The Whalen symptom index—a quality of life measure and the primary endpoint of this study—did not differ significantly for the XQ-9302 and placebo groups at the end of 8 weeks (3.90 + 3.28 vs. 3.80 + 4.44, p = 0.96). Plasma viral load at baseline was 4.65 + 0.53 log for the XQ-9302 group and 4.33 + 0.55 log for the placebo group, equivalent values for the two groups (p = 0.18). At week 8, plasma viral load was 4.69 + 0.52 log for the drug group and 4.39 + 0.58 for the placebo group, also not a significant difference (p = 0.23). No significant differences were seen with either immunological secondary endpoint variable (CD4 + T cell counts and the percentage of T cells that are CD4+, or T4%) at study completion (p >0.05).

These results fail to support the efficacy of XQ-9302 in improving quality of life for HIV positive individuals, or as an antiretroviral treatment.

The full study report was published in the Winter '98/'99 issue of Searchlight.

Principal Investigator:
Stephen J. Brown, M.D.

AIDS Research Alliance acknowledges and appreciates the generous support of the John Lloyd Foundations which made this study possible.