A randomized, open-label, comparative trial of zidovudine plus lamivudine versus zidovudine plus lamivudine plus didanosine in antiretroviral-naive HIV-1-infected Thai patients.

OBJECTIVE: To assess the efficacy and tolerability of a triple nucleoside reverse transcriptase inhibitor combination of zidovudine, lamivudine, and didanosine therapy. DESIGN: A randomized open-label trial. PATIENTS: Antiretroviral-naive HIV-infected patients with CD4+ cell counts of 100 to 500 cells/microl. METHODS: A total of 106 patients were randomly assigned to 300 mg of zidovudine (200 mg for body weight <60 kg) twice daily plus 150 mg of lamivudine twice daily plus 200 mg of didanosine (125 mg for body weight <60 kg) twice daily (n = 53) or to zidovudine plus lamivudine (n = 53) for 48 weeks. MAIN OUTCOME MEASURES: Degree and duration of reduction of HIV-1 RNA load and increase in CD4+ cell counts from baseline and development of drug-related toxicities. RESULTS: At 48 weeks, triple drug therapy showed greater declines in plasma HIV-RNA levels from the beginning of treatment than double drug therapy (1.86 vs. 1.15 log10 copies/ml, respectively; p <.001). The proportions of patients with HIV-RNA <50 copies/ml in an intention-to-treat analysis were 54.7% (29 of 53 patients) and 11.3% (6 of 53 patients) in the triple and double drug therapy, respectively (p =.001). There was no significant difference in increase of CD4 count. CONCLUSION: Triple drug therapy with zidovudine, lamivudine, and didanosine was significantly more effective in inducing sustained immunologic and virologic responses than the double combination of zidovudine and lamivudine.

A comparative study of tuberculin skin test reactivity between asymptomatic HIV-1 seropositive subjects and healthy volunteers.

During November 1993-October 1994 tuberculin skin test reactivity (PPD-Thai Red Cross: 0.1 ml of 10 IU) was determined among 399 asymptomatic HIV-1 positive subjects and 405 healthy volunteers, 10% (40/399) had PPD-TRC induration 0-2 mm compared with 4.2% (17/405) (p = 0.001) and 43.4% (173/399) had induration > or = 10 mm compared with 53.8% (218/405) (p = 0.003) of healthy volunteers. However, the percentage of the PPD-TRC induration 5-9 mm was similar among HIV-1 seropositive subjects and healthy volunteers as 37.6% (150/399) vs 34.8% (141/405) (p = 0.4). The mean PPD-TRC reaction of HIV-seropositive subjects were 6.4 +/- 0.9 mm vs. 11.0 +/- 0.5 mm among those with CD4 lymphocyte counts 200-299 cells/mm3 compared with those > or = 300 cells/mm3 (p < 0.001). We provide support for use of induration of > or = 5 mm of PPD-TRC skin reaction for evidence of latent infection with Mycobacterium tuberculosis as the CDC recommendation in asymptomatic HIV-seropositive subjects. Consideration of tuberculosis chemoprophylaxis should have benefit, particularly in areas where M.tuberculosis is highly prevalent such as Thailand. However, among HIV-1 seropositive carriers with negative tuberculin (PPD-TRC) skin tests, there needs to be a careful evaluation and follow-up for evidence of tuberculous infection.

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.

HIV infection in male patients attending a sexually transmitted disease clinic.

Three hundred and fifty-two heterosexual males, attending a sexually transmitted disease clinic at Siriraj Hospital from December 1989 to February 1991 were studied for the prevalence of HIV infection. Of these, 334 men reported prostitutes as the main source of their sexually transmitted disease. No one had received blood transfusion in the last 5 years, and there was no history of intravenous drug use, homosexuality or bisexuality. HIV antibody was found in the sera of 24 men (6.8%). HIV seropositivity was associated with serologic makers of syphilis (P < 0.05) but was not associated with present genital ulcers on physical examination or other STDs. These data indicate the high rate of female prostitutes to male transmission of HIV infection in the presence of sexually transmitted disease and confirms the relationship between syphilis and HIV infection. HIV/AIDS educational programmes and campaigns to promote condom use among prostitutes and clients are an urgent need in Thailand.

PIP: The study subjects were recruited among heterosexual men attending the male sexually transmitted disease (STDs) clinic operated by the Dermatology Unit, Siriraj Hospital, Mahidol University, Bangkok, Thailand. The subjects had no history of intravenous drug use, homosexuality, or bisexuality, had not received blood transfusion in the preceding 5 years, and claimed that they had contracted the disease from prostitutes. Between December 1989 and February 1991, 352 men enrolled in the study who had a median age of 28 years (range 15-63 years). The participants completed a questionnaire about occupation and clinical symptoms of STDs. Sera were assayed for VDRL and TPHA. HIV antibody screening was performed by gel particle agglutination or ELISA technique, and the specimens were confirmed as positive by HIV antibody Immunoblot technique. Of the 328 HIV seronegative men, 44% had nonspecific urethritis, 13.3% had gonorrhea, 13.1% had genital ulcers (including syphilis and chancroid), and 7.6% had syphilis (including positive VDRL or TPHA 1:160). 334 of 352 men (94.9%) reported prostitutes as the source of their STDs. HIV antibody was detected in 19 (5.4%) of 352 men. Only 100 of the 333 men whose first HIV antibody was negative returned to the clinic for a second HIV antibody test within 12 weeks, and HIV antibody was detected in 5 (5.0%) of these 100 men. Thus, the HIV antibody was found in a total of 24 (6.8%) of 352 men. This rate was 15 times the rate found in blood samples from healthy donors at Siriraj Hospital during the period between 1989 and 1990. The HIV seropositivity was significantly associated with syphilis (including positive VDRL or TPHA 1:160), but was not associated with genital ulcers (including syphilitic ulcer and chancroid). None of the 24 seropositive men had clinical evidence of AIDS-related complex or full-blown AIDS. The lack of association between HIV seropositivity and genital ulcer remains to be further investigated.