Social harms in injecting drug users participating in the first phase III HIV vaccine trial in Thailand.

OBJECTIVE: To study related social harms due to identification with a group of participants in an HIV-1 vaccine trial who are potentially high risk for HIV/AIDS. MATERIAL AND METHOD: Two thousand five hundred forty six injecting drug users (IDU) were enrolled in a 36-month vaccine trial. Volunteers received education and risk reduction counseling at every six-month study visit. Social harms were not actively solicited, but volunteers were encouraged to report any during the process of counseling at every six-month visit. If a social harm was reported, a questionnaire was administered and the harm was tracked If necessary, clinic staff assisted in resolving the social harm. RESULTS: Thirty-nine social harms were reported by 37 participants; 33 (84.6%) were disturbances in personal relationships, three (7.7%) in employment, one (2.6%) was medically related, one (2.6%) was related to admission in the military and one (2.6%) was related with misbelieve about the vaccine. The most common reason for disturbances in personal relationships was suspicion of HIV infection (n=20). The impact of these harms on quality of life was characterized as minimal by 31 (79.5%) participants, as moderate by seven (17.9%), and as major by one (2.6%). All social harms were documented to be resolved by the end of the study. CONCLUSION: A few participants reported study-related social harms during the course of the trial. Most harm had minimal impact and all could be resolved by the end of the present study.

Efficacy of ivermectin treatment of cutaneous gnathostomiasis evaluated by placebo-controlled trial.

Previous studies have revealed that ivermectin treatment for gnathostomiasis can reduce parasitic loads in animals and make recurrent subcutaneous swelling subside in 76% of patients. Our study aimed to evaluate the efficacy of ivermectin for cutaneous gnathostomiasis treatment in a placebo-controlled trial. This study was a prospective randomized placebo-controlled study performed at The Bangkok Hospital for Tropical Diseases, Mahidol University, Thailand. Thirty patients with a serologically confirmed diagnosis of cutaneous gnathostomiasis were enrolled. Seventeen patients in the ivermectin treated group received a single dose of 12 mg ivermectin (200 microg/kg bodyweight), while 13 patients in the control group received a single dose of 40 mg of vitamin B1. The follow-up period was 1 year. Of the 17 patients, 7 (41.2%) responded to ivermectin, while no patient responded to placebo. The mean (95% Cl) time to the first recurrence of subcutaneous swelling with ivermectin and in the placebo groups were 257 (184-331) and 146 (42-250) days, respectively, (p=0.102). Although this study revealed no significant difference in the mean time to first recurrence of swelling between the ivermectin and placebo groups, there was a trend towards ivermectin efficacy against gnathostomiasis in previous animal and human studies. Further studies with different doses of ivermectin and larger sample sizes, and close monitoring for ivermectin tolerability and treatment response are necessary to confirm an efficacy of ivermectin.

Tolerability of ivermectin in gnathostomiasis.

At present, no universally-accepted effective treatment for cutaneous gnathostomiasis is available. At the Hospital for Tropical Diseases, Mahidol University, albendazole 400 mg twice a day for 14 days is commonly prescribed for patients diagnosed with cutaneous gnathostomiasis. The efficacy of albendazole to induce outward migration of the parasite was less than or around 20% in 2 studies. Research for alternative, more efficacious treatment, is needed. In this prospective open-labeled study, we assessed the safety of ivermectin in 20 Thai patients diagnosed with cutaneous gnathostomiasis. Ivermectin, one time only, at dosages of 50, 100, 150, or 200 microg/kg bodyweight, was given orally to 4 groups of patients, 5 patients each group. Adverse events were recorded and laboratory tests were obtained before and after treatment. No serious adverse events occurred in this study. Forty adverse events were possibly related to ivermectin. The adverse events were malaise (35%), myalgia (30%), drowsiness (30%), pruritus (20%), nausea/vomiting (20%), dizziness (15%), diarrhea (15%), feeling of shortness of breath (10%), feeling of palpitations (10%), constipation (5%), anorexia (5%), and headache (5%). These adverse events were self-limited and not dose-related. Laboratory abnormalities were found in 3 patients (15%). Transient microscopic hematuria, pyuria, and mildly elevated liver enzymes were found in 1 patient each. Ivermectin single dose, of 50,100, 150, and 200 microg/kg bodyweight, is considered safe in Thai patients. Future trials of ivermectin on human gnathostomiasis may be performed using dosages up to 200 microg/kg bodyweight.

Association of intestinal helminths with decreased liver size and sCD23 concentration during falciparum malaria.

To determine if intestinal helminths and the CD23/nitric oxide pathway had an influence on liver size, we conducted a cross-sectional study on 438 patients with confirmed P. falciparum malaria admitted at the Hospital for Tropical Diseases in Bangkok. For all patients the liver size was measured as number of centimeters below the rib cage, a stool examination was conducted, and CD23 and reactive nitrogen intermediates were measured. The median liver size was smaller in helminth-infected patients than in helminth-free patients (chi2 for trend = 9.1, p = 0.003). Liver size significantly increased with the concentration of sCD23 (p < 0.0001). The median sCD23 concentration (OD) was significantly lower in helminth-infected patients than in helminth-free patients, respectively 0.33 (quartiles 0.24-0.57) and 0.45 (quartiles 0.27-0.59), (p = 0.01). There was a negative correlation between sCD23 concentrations and RNI (Spearman's rho = -0.40, p < 0.0001). All the above results remained significant after controlling for potential confounders. These results are compatible with a CD23/NO-mediated decrease in liver size in helminth-infected patients.

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.

Clinical and mycological responses to fluconazole and fluconazole MIC in oropharyngeal candidiasis in HIV-infected patients.

INTRODUCTION: OPC is a common opportunistic infection in HIV-infected patients. Although some patients are asymptomatic, progression of the disease may occur leading to esophageal candidiasis. Fluconazole resistant candidiasis has been reported in several international studies. OBJECTIVES: This study aimed to test the MICs (minimal inhibitory concentrations) to fluconazole of Candida species isolated from mouthwash specimens of 54 HIV positive patients with oral candidiasis. Clinical and mycological responses to fluconazole were also assessed in 16 patients. MATERIAL AND METHOD: This was a prospective study. Mouthwash specimens were cultured on sabouraud dextrose agar twice. Candida species identification was performed and MICs for fluconazole were obtained using NCCLS guidelines. Clinical and mycological responses were assessed on day 14 and 42 in 16 patients who received a 14-day course of fluconazole. RESULTS: 48/54 patients (88.89%) were found to carry pure C. albicans. The other 6 patients (11.11%) had mixed Candida species on cultures. Among these 6 patients, 5 patients had mixed C. albicans and C. glabrata, and 1 patient had C. albicans and C. krusei. Fluconazole MICs of C. albicans, C. glabrata, and C. krusei ranged from 0.125-32 (median=0.250), 4-64 (median=2), and 8 g/L respectively. This study showed that the MICs to fluconazole of oropharyngeal Candida was a good predictor of the therapeutic responses.

Mycobacterium tuberculosis infection among HIV/AIDS patients in Thailand: clinical manifestations and outcomes.

A one year retrospective study, was conducted at Bamrasnaradura Hospital, Nonthaburi Province, Bangkok, Thailand, of 271 subjects with both TB and HIV/AIDS. Single males (median age group 31 to 40 years) were most likely to develop co-infection. The commonest clinical manifestations on initial presentation included a low grade fever, cough, weight loss, lymphadenopathy with pancytopenia, and lung infiltrates. Multi-drug resistant TB (MDR-TB) was found in 26.6% of the subjects which was significantly associated with a past history of anti-TB treatment (p = 0.005; OR=2.5); it was also significantly associated with disseminated TB (p = 0.022; OR=1.9) and mortality (p= 0.013; OR=2.8). Analysis of clinical outcomes showed that 46.7% were lost to follow-up and 13.3% had died by the time of follow-up. Among those who survived, only 11.4% had been successfully treated; the rest had not improved due to relapse (2.9%), therapeutic failure (8.8%), treatment in progress (5.9%), and failure to complete treatment (10.7%).