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• W1969962124 abstract "The clinical course of AIDS was drastically changed in the 1990s with the advent of highly active antiretroviral therapy (HAART). It led to sustained reductions in HIV-1 replication, rise in CD4+ T-cell count, and concomitant immune reconstitution, resulting in significant reductions in morbidity and mortality [1]. These benefits, however, have been achieved at the cost of considerable drug toxicity and monetary expense. Particularly disheartening is the realization that HAART alone will not cure HIV-1 infection because of the existence of persistent viral reservoirs, which ultimately rekindle viral replication once therapy is stopped [2]. So, to explore a new idea to control AIDS effectively thereby has become an urgent need. As summarized in all clinical research in the area of AIDS treatment in these years, interleukin (IL)-2 is considered to be effective, though there have been conflicting reports [3–8]. However, in all these studies, they administered IL-2 with its invasive formulation with injection by vein, muscle or subcutaneously, which was not well tolerated and could not easily be put into practice. We improved this method by adopting a new method of administration of IL-2 through rectal mucosa, that is to place IL-2 in rectal directly where it was absorbed by rectal mucosa and observe its effect on the change of CD4+ T-cell count and HIV RNA load. A total of seven volunteer HIV/AIDS patients of whom three were treated with ART for 3–5 months were recruited in this study, (for patients' information, see Table 1). The volunteer patients signed the clinical trial consent after being well informed about IL-2-restricted factors such as sensitivity and severe heart disease by a doctor. Guided by doctors, the patients dissolved IL-2 freeze powder into liquid and then sucked it out with a 5-ml syringe. They took off the pinhead, put 5–10 cm of the syringe into the rectum through the anus, inserted the liquid, and then lay prone on bed for 10–30 min. All this was done by patients themselves. Each patient was administered IL-2 4 MIU through the rectal mucosa on the first, third and fifth day during the first week, and then given IL-2 4 MIU once every week. The total treatment period was 1 month for every patient. Blood samples were collected pre-IL-2 treatment at week 0 and post-IL-2 treatment at weeks 1, 2, 3 and 4 for laboratory test. The laboratory test included CD4+ T-cell count and CD8+ T-cell count, HIV RNA load and liver function, renal function, full blood cell count, glycemia, and so on.Table 1: Patient information and laboratory test results.One month later, all seven patients had no improvement in CD4+ T-cell count. However, in the four patients who were not treated with ART, HIV RNA load reduction of about 0.3–1.5 log10 copies/ml was observed, which is almost equally effective as HAART. For more details, see Table 1. CD4+ T-cell count had no significant improvement over a short-treatment period. However, most of the patients reported that their quality of life and clinical condition improved. Two patients said that their facial rash disappeared and four patients said that their spirits had improved. One patient reported a suspected immune reconstitution inflammatory syndrome (IRIS) of tuberculosis recurrence after 3 days of IL-2 administration. One patient said that throat pain mitigated after 2 days of IL-2 treatment. In particular, the side effects of IL-2 administration through the rectal mucosa were less severe than those of administration through vein, muscle or subcutaneously. Even when given a large dosage of IL-2, only five patients had dizziness, light headache, weariness, and muscle ache, which disappeared within 24 h without any management; not a single patient had fever and rash. The laboratory test showed that there was no change in liver function, kidney function, full blood cell count, and blood glucose levels during pre-IL-2 and post-IL-2 treatment. It is primarily identified that the means of treatment was safe. In recent years, IL-2 has proved effective in CD4+ T-cell count rise, reducing opportunistic infection, and recent studies showed that it worked independently on viral load reduction [5–8]. Particularly, a recent report has shown that IL-2 has been the most extensively studied inducing agent to date and two studies demonstrated reductions in the latent reservoir after IL-2 treatment was added to HAART [9,10]. But all these effects were mitigated by its invasive formulation of injection by vein, muscle or subcutaneously, which is inconvenient and has many side effects. We improved this means and administered IL-2 through rectal mucosa, resulting in less severe side effects and achieved satisfying outcome. As it is easy to handle, patients can practice the treatment by themselves, combine it with long-term ART, and implementation of IL-2 could be possible widely. The rectal mucosa has abundant capillaries. IL-2 is directly exposed to the rectal mucosa, epidemic cell clearance is expanded, and capillaries are enlarged that contribute to the absorbance of IL-2. The rectal system has a rich lymphoid tissue and blood supply. IL-2 reaches this compartment first to work directly. This process can avoid liver clearance around 50%, so that related side effects are reduced. Particularly in recent years, Mehandru et al.[11,12] reported that primary HIV-1 infection has a responding gastrointestinal CD4+ T-cell count reduction. This finding strongly suggests that intervention via the gastrointestinal tract by some way will bring a good result. Although this is a very small study, the good outcome will encourage us to continue this work. It also gives an indication to all the researchers worldwide who endeavor to look for new means to treat AIDS patients." @default.
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• W1969962124 date "2008-10-18" @default.
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• W1969962124 title "A study of rectal mucosa administration of IL-2 in treatment of HIV/AIDS: a novel method for the treatment of HIV/AIDS" @default.
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• W1969962124 doi "https://doi.org/10.1097/qad.0b013e328314b60f" @default.
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