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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.
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