OBJECTIVES. To evaluate the effectiveness of QX-9302—a purified, precise mixture of 20 Chinese herbs—against infection with human immunodeficiency virus in vitro and in the clinic.

DESIGN. In vitro cell culture assay, heavy metal content analysis, and pilot non-randomised clinical trial.

SETTING. Drug rehabilitation centre and municipal surveillance centre, Shanghai, China.

PATIENTS. Forty-eight patients who had various clinical histories, such as drug abuse, cancer, and infection with human immunodeficiency virus, participated in the clinical study.

INTERVENTION. During the clinical trial, multiple 15-day courses of XQ-9302 10.8 g/d were given to participants.

MAIN OUTCOME MEASURES. CD4 count, P24 antigen level, level of antibody against human immunodeficiency virus, numbers of copies per millilitre of human immunodeficiency virus in the plasma (viral load), and side effects.

RESULTS. XQ-9302 protected cultured MT4 cells from infection with human immunodeficiency virus in vitro. Clinical tests showed that the herbal formula relieved the symptoms of acquired immunodeficiency syndrome and enhanced CD4 counts in patients infected by the human immunodeficiency virus. There were no observable side effects, even after taking the drug for several months. In three patients who had acquired immunodeficiency syndrome, treatment with XQ-9302 reduced the magnitude of the viral load by more than 1 log.

CONCLUSION. XQ-9302 not only improves the immune function of patients infected with the human immunodeficiency virus, but also interrupts viral replication and slows the progression of the disease without detectable side effects. In addition, the heavy metal content of XQ-9302 is well within safety levels set by the Government of China.

Key words: Acquired immunodeficiency syndrome, drug therapy; Drugs, Chinese herbal/therapeutic use; Evaluation studies; Follow-up studies; HIV antibodies/blood; Virus replication

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