Peru-15 (Choleragarde(®)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand.

BACKGROUND: Many areas with endemic and epidemic cholera report significant levels of HIV transmission. According to the World Health Organization (WHO), over 95% of reported cholera cases occur in Africa, which also accounts for nearly 70% of people living with HIV/AIDS globally. Peru-15, a promising single dose live attenuated oral cholera vaccine (LA-OCV), was previously found to be safe and immunogenic in cholera endemic areas. However, no data on the vaccine's safety among HIV-seropositive adults had been collected. METHODS: This study was a double-blinded, individually randomized, placebo-controlled trial enrolling HIV-seropositive adults, 18-45 years of age, conducted in Bangkok, Thailand, to assess the safety of Peru-15 in a HIV-seropositive cohort. RESULTS: 32 HIV infected subjects were randomized to receive either a single oral dose of the Peru-15 vaccine with a buffer or a placebo (buffer only). No serious adverse events were reported during the follow-up period in either group. The geometric mean fold (GMF) rise in V. cholerae O1 El Tor specific antibody titers between baseline and 7 days after dosing was 32.0 (p<0.001) in the vaccine group compared to 1.6 (p<0.14) in the placebo group. Among the 16 vaccinees,14 vaccinees (87.5%) had seroconversion compared to 1 of 16 placebo recipients (6.3%). V. cholerae was isolated from the stool of one vaccinee, and found to be genetically identical to the Peru-15 vaccine strain. There were no significant changes in HIV viral load or CD4 T-cell counts between vaccine and placebo groups. CONCLUSION: Peru-15 was shown to be safe and immunogenic in HIV-seropositive Thai adults.

A randomized, controlled 24-week study of intermittent subcutaneous interleukin-2 in HIV-1 infected patients in Thailand.

OBJECTIVES: To assess the immunological and virological effects, safety profile and feasibility of subcutaneous interleukin-2 (scIL-2) therapy in an HIV-infected Thai population. DESIGN: Seventy-two patients with baseline CD4 cell count of > or = 350 x 10(6)/l and no history of opportunistic infection were randomized to receive antiretroviral therapy plus scIL-2 (scIL-2 group) or antiretroviral therapy alone (control group). scIL-2 was administered at one of three doses for at least 24 weeks. The main measure of treatment efficacy was change in CD4 cell count. RESULTS: The time-weighted mean change in CD4 cell count from baseline to week 24 was + 252 x 10(6)/l for the scIL-2 group compared with + 42 x 10(6)/l for the control group (P< 0.0001). Changes in plasma HIV RNA were not significantly different between the groups over the same time period: there was a 0.83 log10 copies/ml decrease for the scIL-2 group and a 0.70 log copies/ml decrease for the control group (P= 0.362). CONCLUSIONS: This study provides the most extensive experience of scIL-2 therapy in HIV-1 infected women and Asians, and demonstrates the immunological efficacy, tolerability and feasability of scIL-2 therapy in this population. Data from this study were instrumental in guiding the selection of the scIL-2 dosing regimen for ongoing phase III trials.

The mounting medical care cost for adult AIDS patients at the Faculty of Medicine, Siriraj Hospital: consideration for management.

From January 1993 to December 1995, case records of adult AIDS and HIV symptomatic patients admitted in the Department of Medicine, observation room and HIV Counseling Clinic were reviewed for the medical care cost of the patients based on the 1995 value of the Thai baht. In the three years, a total of 196, 227 and 182 adult AIDS case were admitted as in-patients respectively. The median duration of admission was 14 days. The leading causes of admission were tuberculosis, cryptococcal meningitis, Pneumocystis carinii pneumonia, diarrhea, salmonellosis and toxoplasmosis. An increase in the number of AIDS patients in the observation room was observed: from 572 cases in 1993 to 1,205 cases in 1995. In addition, approximately 600 AIDS cases were followed up at four to eight week intervals. The analysis of the data found an average medical care cost for hospitalized patients to be 1,452 baht per day while in the observation room it was 1,509 baht per day and 1,132 baht per month for the patients attending the HIV and Counseling Clinic. Because of the higher number of cases and the limited number of admission beds, only 15 per cent of AIDS patients in the observation room could be admitted as hospitalized patients. At present, it is urgent that a referral network be established among all university hospitals, all government hospitals and health centers. In this way, the more advanced medical facilities can serve as a primary diagnostic center which can refer patients for care and follow-up based on an established referral system. In addition, the development of a hospice service and community care is needed for cases in the terminal stage of the illness.

PIP: This study examines case records of adult AIDS and HIV symptomatic patients admitted to the Siriraj Hospital's Department of Medicine during January 1993 and December 1995. The study aims to determine the medical care cost of adult AIDS patients admitted to the observation room, hospital, and HIV and Counseling Clinic and to determine which factors are the most costly. An AIDS diagnosis is determined according to the Thailand Ministry of Health protocols. Costs include medication cost, facility cost, and testing in 1995 baht prices. Government-supplied medicines are not included in the cost. AIDS cases numbered 196, 227, and 182 adult persons in the respective years 1993, 1994, and 1995. The median CD4 lymphocyte count was 59 cells/mm. The median duration of visit was 14 days. AIDS patients occupied 5.4-7% of inpatient admission beds. 17.6-18.8% of patients were readmitted during the year. 26.4% to 33.7% died before discharge. The leading cause of admission was tuberculosis cryptococcal meningitis, pneumocystis carinii pneumonia, diarrhea, salmonellosis, and toxoplasmosis. The number of AIDS cases admitted to the observation room for 2-5 days increased from 572 cases in 1993 to 1205 cases in 1995. However, due to space limitations, only 15% of AIDS patients under observation were admitted to the hospital in 1995. About 600 cases each year were followed up for complications. Medical care costs were 1452 baht/day/patient for admissions; 1509 baht/day/patient in an observation room; and 1132 baht/month/patient for HIV counseling care. The average cost for all adult AIDS patients/year rose from 18,726,176 baht to 26,812,204 baht during 1993-95. Medicine costs almost tripled for treating cryptococcoses. Treatment costs are lower in provincial hospitals. There is a need for the establishment of a referral network, hospice care, and low costs for treatment.

Risk factors for HIV infection among Thai laborers during 1992-1993.

From June 1992 to May 1993, 39,939 Thai men attended the clinic for laborers going abroad at Siriraj Hospital in Bangkok for a pre-assignment physical exam and mandatory blood screen for HIV and syphylis. Of this total, 438 tested positive for HIV antibody (1.1%). Of these, 215 men returned for post test interview and physical exam and were compared with 1,348 men randomly selected HIV-1 seronegative men. None of the HIV-1 seropositive had a history of injecting drug use or had received blood transfusion in the past seven years. HIV-1 seropositivity was associated with the TPHA serological marker for syphylis > 1.160 (p = 0.015, odd ratio 1.8), history of urethritis (p = 0.009, odd ratio 1.92) (Table 4). This study found that HIV-1 seropositive men were mostly single, were likely to be from the rural northern provinces of Thailand or Bangkok. History of purchase of low-fee commercial sex and less condom use were significantly associated with HIV-1 seropositivity as was a history of STD in the year prior to interview. Information on HIV disease and pre-test/post test counselling is needed for Thai laborers who are applying for work abroad to countries which require HIV and syphylis screening. In this effort, the Ministry of Labor and Social Welfare, the Ministry of Public Health and the clinic for laborers going abroad should join forces to provide this service. This will serve to increase awareness and self-determination among an increasingly vulnerable segment of the population who also have the potential to spread HIV infection to their spouse and other sex partners.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: According to data from the Siriraj Hospital Medical School, where mandatory human immunodeficiency virus (HIV) screening is provided for Thais who travel abroad as contract laborers, the incidence of HIV infection in this population group increased from 0.25% in 1989 to 1.16% in 1992. To assess the risk factors associated with this trend, interviews were conducted with every 25th laborer out of the 39,939 men who presented to the clinic from June 1992 to May 1993. This yielded a sample of 1786 men, 438 of whom were HIV-positive. However, only 215 HIV-positive men returned to the clinic, resulting in a sample of 1563 men (average age, 31.4 years). None of the seropositive subjects had a history of intravenous drug use or blood transfusion. HIV-infected laborers were significantly more likely than their noninfected counterparts to be single, from the Northern and Central provinces, and to be less educated and unskilled. 75.3% of HIV-positive men, compared to 19.5% of seronegative men, had engaged in commercial sex in the past year and were more likely than their counterparts to have visited a low fee (under 100 baht) brothel-based prostitute. The rate of condom use during commercial sex encounters was 59.3% among seropositive men compared to 68.9% among seronegative men. 53.7% of seropositive men, compared to 33.1% of their seronegative counterparts, reported having a sexually transmitted disease (especially urethritis) in the preceding year. Given the threat that HIV-infected itinerant laborers will transmit the virus to others in their home provinces, it is recommended that HIV prevention education become a part of labor recruitment; also urged are continued efforts to promote the goal of 100% condom use in Thailand's commercial sex industry.