LYMPHATIC TISSUE SAMPLING TO QUANTITATE TISSUE ASSOCIATED HIV 1

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In recent Phase-III studies using combinations of nucleoside analogues and protease inhibitors, most subjects were rendered aviremic as judged by RNA determinations and in some series by culture. Our group, using a combination of AZT/3TC and nelfinavir, has achieved this in 11/11 subjects in 12 weeks. Similarly, in our studies nearly all newly HIV-infected subjects treated with AZT/3TC and either ritonavir or indinavir, both potent bioavailable inhibitors of HIV-1 protease have become aviremic as determined by viral RNA determination and PBMC co-culture. However, the significance of prolonged aviremia remains unclear. This study will involve sampling lymphatic tissue of HIV-infected subjects who as a result of treatment have had a period of at least nine months of aviremia. The goal is to provide additional diagnostic criteria, which may be useful to identify subjects that may be advised to discontinue treatment . If no evidence of active viral replication in lymphatic tissue were to be found it would suggest that prolonged aviremia is indicative of "viral burnout." Lymphatic tissue will be subjected to viral culture as well as PCR and in-situ PCR techniques to assess for the presence of active viral replication. This critical data is essential to answer the question whether HIV-1 infection can be cured in a human host.