TRTMNT W/TENOFOVIR DF,EMTRICITABINE,& LOPINAVIR/RITONAVIR VS NO THERAPY IN HIV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is being done to learn if treating people during early HIV infection is beneficial. In other words, this study will evaluate how safe and effective a combination of anti-HIV drugs (Tenofovir DF, Emtricitabine and Kaletra) is for people with recently acquired HIV infection. It is known that combination anti-HIV drugs decreases the amount of virus in the blood (viral load) and improve the immune system. However, these drugs also have short-term and long-term side effects that are also considered when people decide whether or not to begin anti-HIV medicine. The opinions of HIV treatment experts regarding when to start anti-HIV medicine do change as we learn more about the anti-HIV drugs and their good and bad effects over time. The three drugs used in this study have been approved of by the U.S. Food and Drug Administration for the treatment of people with chronic HIV infection. There are treatment guidelines for persons with chronic, established HIV infection. We do not know if the situation may be different for persons recently infected with HIV. For several years, investigators have been studying people with recently acquired HIV infection, and there is some evidence that aggressively treating people diagnosed early during their infection may be of some benefit. The part of the immune system that fights HIV infection may be better preserved if treatment is begun early. Early treatment of HIV infection may possibly make it less likely that the infection is spread to another person. However, we still do not know whether or not treating early HIV infection makes a difference in the long run. We do not know if the side effects associated with beginning treatment earlier are justified. During this study, one group of subjects will be told to immediately begin taking anti-HIV drugs for 9 months. The subjects who do not begin anti-HIV drugs, will start anti-HIV drugs only if their CD4+ count goes low or their viral load stays high for a long period of time. At the end of the study, the viral load in persons who received anti-HIV drugs at the beginning of the study will be compared to the viral load in persons who did not start anti-HIV drugs, to see if the subjects who received the 9 months of treatment have a lower viral load. We do know that people who keep lower viral loads tend to do better than people with higher viral loads. This study is designed so that anyone who needs treatment for HIV because of high viral load, immune system decline or symptoms related to HIV infection will be offered treatment.