Participation in randomized trials in developing countries.
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Biomedical subjects
Publications and source records attributed to Jintanat Ananworanich.
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Immunization is an important measure to protect HIV-infected children and adults against certain vaccine preventable diseases. However, the antibody response, which is associated with the level of CD4+ T cell count, is frequently impaired in this group of patients. Certain vaccines enhance virus replication and transiently increase HIV viral load. Theoretically, vaccination should be given before the immune status of the patients is suppressed. Inactivated vaccines are generally safe and are beneficial for HIV-infected patients. These vaccines should be administered at appropriate age recommended for immunocompetent individuals. Live vaccines should be used with caution since some of the vaccines may be harmful to patients with severe immunologic suppression. Recommendations for immunization in HIV-infected patients may differ from country to country, depending on the availability and affordability of each vaccine, and the prevalence of each preventable disease. Vaccine trial in HIV-infected patients is needed in order to establish the most appropriate vaccine recommendation for this group of patients.
BACKGROUND: Scheduled treatment interruptions are being evaluated in an effort to decrease costs and side effects of highly active antiretroviral therapy (HAART). A schedule of 1 week on and 1 week off therapy offers the promise of 50% less drug exposure with continuously undetectable HIV RNA concentration. METHODS: In the Staccato study 600 patients on successful HAART were to be randomized to either continued therapy, CD4-guided therapy, or one week on, one week off therapy. A scheduled preliminary analysis evaluated effectiveness in the 1-week-on-1-week-off arm. RESULTS: Of 36 evaluable patients, 19 (53%) had two successive HIV RNA concentrations > 500 copies/ml at the end of the week off therapy, and were classified as virological failure. Most of those who failed took didanosine, stavudine, saquinavir, and ritonavir (11 patients). In these patients, there was no evidence of mutations suggestive of drug resistance, and plasma saquinavir levels were within the expected range. Two of three patients failing on triple nucleotides had drug resistance mutations, but nonetheless responded to reintroduction of triple nucleotide therapy. One of two patients taking nevirapine, and one of eight taking efavirenz, also failed. Both had resistance mutations at the time of failure, but not at baseline. CONCLUSIONS: The 1-week-on-1-week-off schedule, as tested in the Staccato study, showed an unacceptably high failure rate and was therefore terminated.
In a structured treatment interruption (STI) trial, 3 of 23 patients in a CD4 cell count-guided treatment arm developed recurring thrombocytopenia associated with the interruption of antiretroviral therapy. All 3 patients had slightly low or normal platelet counts before initiating antiretroviral therapy. STI may play a role in inducing thrombocytopenia in patients with human immunodeficiency virus infection.
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We report a 7-year HIV-1 clade A/E-infected child untreated with antiretroviral therapy who had positive HIV antibody testing but undetectable plasma HIV-1 RNA by Roche Amplicor version 1.5 and bDNA version 3.0. DNA PCR was positive by methods using gag/pol primers but not env/pol primers. The patient had strong HIV-1-specific cytotoxic T lymphocyte responses, which likely contributed to her low viral burden and undetectable plasma HIV-1 RNA.