Safety and efficacy of CKBM-A01, a Chinese herbal medicine, among asymptomatic HIV patients.

Complementary remedies represent a potential alternative treatment for chronic diseases, including HIV/AIDS cases not meeting criteria for using highly active antiretroviral therapy (HAART). This study evaluated the safety and efficacy of CKBM-A01, a Chinese herbal medicine, and patient quality of life (QoL). Asymptomatic HIV patients with CD4 counts of 250-350 cells/microl were recruited into this open-labeled trial. Liquid CKBM-A01 was prescribed for a 36-week period. Study participants recorded all symptoms themselves on diary cards. Study parameters, including CD4 cell counts, HIV viral loads, and blood chemistry, were periodically monitored and questionnaires were used to assess QoL and to help with risk reduction. Eighteen volunteers, mean age (+/- SD) 32.07 (+/- 6.88) years, had a median (interquartile range, IQR) baseline CD4 count of 292 (268.50-338.25) cells/microl. No serious drug-related adVerse events due to CKBM-A01 were detected during the study. Intermittent diarrhea was reported in 55.6%, weakness or skin rash/itching in 50%, and increased bowel movement in 33.7%. No significant changes in log viral load or CD4 cell counts were observed at the end of the study. Most of the volunteers (72.2%) expressed satisfaction with CKBM-A01 and had a positive perception. Common colds and nasal symptoms were significantly lower during treatment (p = 0.019). CKBM-A01 appeared to be safe but gave no significant improvement in QoL in asymptomatic HIV patients, and gave no significant improvement in the treatment of HIV based on CD4 cell counts and viral loads.

6-month evaluation of JinHuang Chinese herbal medicine study in asymptomatic HIV infected Thais.

Good results of in vitro study of anti-HIV effects of JinHuang, a Chinese herbal medicine led to in vivo study of safety and efficacy among asymptomatic HIV infected individuals. It was a prospective open study of 21 asymptomatic HIV infected Thai volunteers. Twelve and 9 were female and male, respectively, with mean age of 29.24 +/- 3.94 years. JinHuang preparation, 6 capsules and 2 bottles of liquid formula orally three times a day, was given on an outpatient basis initially for 6 months. Regular close monitoring and follow-up were done. The side effects reported included : increased bowel movements (81%), vague taste, and smell of drug after initiation (52%). No serious adverse event related to JinHuang was detected during study. No significant changes in terms of log viral load and CD4 count were observed after 6-months' duration. Most of the patients felt that the quality of life was better in terms of better appetite, good sleep and healthy during study participation, however, these were subjective.

Evaluation of attitude, risk behavior and expectations among Thai participants in Phase I/II HIV/AIDS vaccine trials.

The Understanding of volunteers in vaccine trials about their role as study participants and their voluntary commitment during the study are always one of the important concerns apart from evaluation of safety and efficacy of vaccine trials, especially in HIV prophylactic vaccine trials. The apprehension of indirectly risky behavior encouragement and deviated expectations among volunteers should be of concern. The current prospective cohort study aimed to assess and monitor the changes of risk behaviors, attitude and expectations among 164 volunteers from 2 studies of different prophylactic HIV vaccines, the Chiron HIV Thai E gp 120/MF59 +/- the Chiron HIV SF52 gp120 and Aventis Pasteur Live Recombinant ALVAC HIV (vCP1521) priming with VaxGen gp120B/E (AIDSVAX B/E) boosting. 113 males and 51 females with a mean age (+/- SD) of 28.82 +/- 7.97 years old were enrolled from October 1997 to December 1998 and February 2000 to April 2001. Education and risk reduction counseling were regularly performed at every visit and questionnaires about risk behaviors, knowledge, attitudes, social influences and expectations were asked at baseline, 4 months and 12 months. No change of potentially HIV transmission related risk behavior was observed during the studies. There was a statistically significant decrease of risk sexual practices from the beginning of the trials (42.2% vs 1%, p < 0.0001). While 35.2 per cent from 62.2 per cent of the volunteers at the beginning of the study continued sexual practice with an identified single sexual partner at the end of the study (p < 0.0001). All of the volunteers expressed the beneficial expectations as knowledge gain, social contribution, feelings of having gained merit and self-benefits from health check-ups.