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Initiative for Vaccine Research. Task Force on Clinical Trials of Dengue Vaccines, 14 November 2002.
Geneva, Switzerland, WHO, 2002. 12 p. (VAB/IVR/VIR2002.03.1)The second meeting of the WHO Task Force on Clinical Trials of Dengue Vaccines was held on 14 November 2002 in Denver, Colorado, USA. The Task Force was established to accelerate the development, evaluation, and introduction of urgently needed dengue vaccine candidates. The main objective of the Task Force is to continue to analyze results on safety, immunogenicity, and efficacy of currently available vaccine candidates in clinical trials and to provide scientific advice on the next steps to be taken, giving special attention to vaccine safety. The meeting reviewed the progress in clinical trials of four live attenuated vaccine candidates. The task force recommended specific activities in support of future development and clinical studies and identified the role of WHO in this process. The meeting was co-sponsored by the Pediatric Dengue Vaccine Initiative. (excerpt)
Journal of Acquired Immune Deficiency Syndromes. 2009 Sep 1; 52(1):106-13.BACKGROUND: Current World Health Organization (WHO) guidelines for treatment of HIV in resource-limited settings call for 2 antiretroviral regimens. The effectiveness and cost-effectiveness of increasing the number of antiretroviral regimens is unknown. METHODS: Using a simulation model, we compared the survival and costs of current WHO regimens with two 3-regimen strategies: an initial regimen of 3 nucleoside reverse transcriptase inhibitors followed by the WHO regimens and the WHO regimens followed by a regimen with a second-generation boosted protease inhibitor (2bPI). We evaluated monitoring with CD4 counts only and with both CD4 counts and viral load. We used cost and effectiveness data from Cape Town and tested all assumptions in sensitivity analyses. RESULTS: Over the lifetime of the cohort, 25.6% of individuals failed both WHO regimens by virologic criteria. However, when patients were monitored using CD4 counts alone, only 6.5% were prescribed additional highly active antiretroviral therapy due to missed and delayed detection of failure. The life expectancy gain for individuals who took a 2bPI was 6.7-8.9 months, depending on the monitoring strategy. When CD4 alone was available, adding a regimen with a 2bPI was associated with an incremental cost-effectiveness ratio of $2581 per year of life gained, and when viral load was available, the ratio was $6519 per year of life gained. Strategies with triple-nucleoside reverse transcriptase inhibitor regimens in initial therapy were dominated. Results were sensitive to the price of 2bPIs. CONCLUSIONS: About 1 in 4 individuals who start highly active antiretroviral therapy in sub-Saharan Africa will fail currently recommended regimens. At current prices, adding a regimen with a 2bPI is cost effective for South Africa and other middle-income countries by WHO standards.
Monitoring antiretroviral therapy in resource-limited settings: balancing clinical care, technology, and human resources.
Current HIV / AIDS Reports. 2010 Aug; 7(3):168-74.Due to the rapid expansion of first-line antiretroviral therapy in resource-limited settings (RLS), increasing numbers of people are living with HIV for prolonged periods of time. Treatment programs must now decide how to balance monitoring costs necessary to maximize health benefits for those already on treatment with the continued demand to initiate more patients on first-line treatment. We review currently available evidence related to monitoring strategies in RLS and discuss their implications on timing of switching to second-line treatment, development of HIV resistance, and clinical outcome.