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Pitisuttithum P Rerks-Ngarm S Bussaratid V Dhitavat J Maekanantawat W Pungpak S Suntharasamai P Vanijanonta S Nitayapan S Kaewkungwal J Benenson M Morgan P O'Connell RJ Berenberg J Gurunathan S Francis DP Paris R Chiu J Stablein D Michael NL Excler JL Robb ML Kim JH 《PloS one》2011,6(12):e27837
Background
A prime-boost vaccination regimen with ALVAC-HIV (vCP1521) administered intramuscularly at 0, 4, 12, and 24 weeks and gp120 AIDSVAX B/E at 12 and 24 weeks demonstrated modest efficacy of 31.2% for prevention of HIV acquisition in HIV-uninfected adults participating in a community-based efficacy trial in Thailand.Methodology/Principal Findings
Reactogenicity was recorded for 3 days following vaccination. Adverse events were monitored every 6 months for 3.5 years, during which pregnancy outcomes were recorded. Of the 16,402 volunteers, 69% of the participants reported an adverse event any time after the first dose. Only 32.9% experienced an AE within 30 days following any vaccination. Overall adverse event rates and attribution of relatedness did not differ between groups. The frequency of serious adverse events was similar in vaccine (14.3%) and placebo (14.9%) recipients (p = 0.33). None of the 160 deaths (85 in vaccine and 75 in placebo recipients, p = 0.43) was assessed as related to vaccine. The most common cause of death was trauma or traffic accident. Approximately 30% of female participants reported a pregnancy during the study. Abnormal pregnancy outcomes were experienced in 17.1% of vaccine and 14.6% (p = 0.13) of placebo recipients. When the conception occurred within 3 months (estimated) of a vaccination, the majority of these abnormal outcomes were spontaneous or elective abortions among 22.2% and 15.3% of vaccine and placebo pregnant recipients, respectively (p = 0.08). Local reactions occurred in 88.0% of vaccine and 61.0% of placebo recipients (p<0.001) and were more frequent after ALVAC-HIV than AIDSVAX B/E vaccination. Systemic reactions were more frequent in vaccine than placebo recipients (77.2% vs. 59.8%, p<0.001). Local and systemic reactions were mostly mild to moderate, resolving within 3 days.Conclusions/Significance
The ALVAC-HIV and AIDSVAX B/E vaccine regimen was found to be safe, well tolerated and suitable for potential large-scale use in Thailand.Trial Registration
ClinicalTrials.gov NCT00223080相似文献2.
Martin M Vanichseni S Suntharasamai P Sangkum U Chuachoowong R Mock PA Leethochawalit M Chiamwongpaet S Kittimunkong S van Griensven F McNicholl JM Paxton L Choopanya K;Bangkok Tenofovir Study Group 《PloS one》2011,6(9):e25127
Background
The Bangkok Tenofovir Study was launched in 2005 to determine if pre-exposure prophylaxis with tenofovir will reduce the risk of HIV infection among injecting drug users (IDUs). We describe recruitment, screening, enrollment, and baseline characteristics of study participants and contrast risk behavior of Tenofovir Study participants with participants in the 1999–2003 AIDSVAX B/E Vaccine Trial.Methods
The Bangkok Tenofovir Study is an ongoing, phase-3, randomized, double-blind, placebo-controlled, HIV pre-exposure prophylaxis trial of daily oral tenofovir. The Tenofovir Study and the Vaccine Trial were conducted among IDUs at 17 drug-treatment clinics in Bangkok. Tenofovir Study sample size was based on HIV incidence in the Vaccine Trial. Standardized questionnaires were used to collect demographic, risk behavior, and incarceration data. The Tenofovir Study is registered with ClinicalTrials.gov, number-. NCT00119106Results
From June 2005 through July 2010, 4094 IDUs were screened and 2413 enrolled in the Bangkok Tenofovir Study. The median age of enrolled participants was 31 years (range, 20–59), 80% were male, and 63% reported they injected drugs during the 3 months before enrollment. Among those who injected, 53% injected methamphetamine, 37% midazolam, and 35% heroin. Tenofovir Study participants were less likely to inject drugs, inject daily, or share needles (all, p<0.001) than Vaccine Trial participants.Discussion
The Bangkok Tenofovir Study has been successfully launched and is fully enrolled. Study participants are significantly less likely to report injecting drugs and sharing needles than participants in the 1999–2003 AIDSVAX B/E Vaccine Trial suggesting HIV incidence will be lower than expected. In response, the Bangkok Tenofovir Study enrollment was increased from 1600 to 2400 and the study design was changed from a defined 1-year follow-up period to an endpoint-driven design. Trial results demonstrating whether or not daily oral tenofovir reduces the risk of HIV infection among IDUs are expected in 2012. 相似文献3.
M. J. Warrell N. J. White S. Looareesuwan R. E. Phillips P. Suntharasamai P. Chanthavanich M. Riganti S. P. Fisher-Hoch K. G. Nicholson S. Manatsathit et al. 《BMJ (Clinical research ed.)》1989,299(6703):830-833
OBJECTIVE--To test the effect of interferon alfa and tribavirin (ribavirin) in patients with rabies encephalitis. DESIGN--An open trial of chemotherapy and intensive care in patients with early rabies. SETTING--The intensive care unit of a Bangkok hospital. PATIENTS--Four conscious men with clinical rabies encephalitis. INTERVENTIONS--Rapid virological diagnosis of rabies. Treatment with intravenous and intraventricular injections of high doses of lymphoblastoid interferon alfa in three patients and tribavirin in one patient. Intensive care was given throughout. MAIN OUTCOME MEASURES--Rabies infection confirmed by antigen detection and virus isolation. Rabies neutralising antibody and specific IgM sought in serum and cerebrospinal fluid. Interferon concentrations monitored before and during treatment in three patients. RESULTS--Interferon alfa treatment produced high concentrations in serum and cerebrospinal fluid. All four patients died after 5 1/2 to 12 1/2 days of treatment with no evidence of virostatic or clinically beneficial effects from either treatment. CONCLUSION--Interferon alfa treatment is not effective in rabies encephalitis. The use of tribavirin warrants further study, possibly combined with new therapeutic methods. 相似文献
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Pravan Suntharasamai Michael Martin Kachit Choopanya Suphak Vanichseni Udomsak Sangkum Pairote Tararut Wanna Leelawiwat Rapeepan Anekvorapong Philip A. Mock Thitima Cherdtrakulkiat Manoj Leethochawalit Sithisat Chiamwongpaet Roman J. Gvetadze Janet M. McNicholl Lynn A. Paxton Somyot Kittimunkong Marcel E. Curlin 《PloS one》2015,10(12)
Background
Rapid easy-to-use HIV tests offer opportunities to increase HIV testing among populations at risk of infection. We used the OraQuick Rapid HIV-1/2 antibody test (OraQuick) in the Bangkok Tenofovir Study, an HIV pre-exposure prophylaxis trial among people who inject drugs.Methods
The Bangkok Tenofovir Study was a randomized, double-blind, placebo-controlled trial. We tested participants’ oral fluid for HIV using OraQuick monthly and blood using a nucleic-acid amplification test (NAAT) every 3 months. We used Kaplan-Meier methods to estimate the duration from a positive HIV NAAT until the mid-point between the last non-reactive and first reactive oral fluid test and proportional hazards to examine factors associated with the time until the test was reactive.Results
We screened 3678 people for HIV using OraQuick. Among 447 with reactive results, 436 (97.5%) were confirmed HIV-infected, 10 (2.2%) HIV-uninfected, and one (0.2%) had indeterminate results. Two participants with non-reactive OraQuick results were, in fact, HIV-infected at screening yielding 99.5% sensitivity, 99.7% specificity, a 97.8% positive predictive value, and a 99.9% negative predictive value. Participants receiving tenofovir took longer to develop a reactive OraQuick (191.8 days) than participants receiving placebo (16.8 days) (p = 0.02) and participants infected with HIV CRF01_AE developed a reactive OraQuick earlier than participants infected with other subtypes (p = 0.04).Discussion
The oral fluid HIV test performed well at screening, suggesting it can be used when rapid results and non-invasive tools are preferred. However, participants receiving tenofovir took longer to develop a reactive oral fluid test result than those receiving placebo. Thus, among people using pre-exposure prophylaxis, a blood-based HIV test may be an appropriate choice.Trial Registration
ClinicalTrials.gov . NCT00119106相似文献5.
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