CLINICAL TRIAL: ENFURVITIDE (T-20) INTENSIFICATION FOR LOW LEVEL VIREMIA (THE LO

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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. We propose to enroll 25 HIV-infected subjects with persistent low level HIV viremia defines as a plasma HIV RNA level of 50 to 1000 copies/mL on a minimum of three occasions separated by at least 12 weeks while on a stable potent antiretroviral regimen (see inclusion criteria). The antiretroviral regimen must be a combination that does not include Enfurvitide but contains two or more active agents of which one must be a non-nucleoside reverse transcriptase inhibitor or a ritonavir-boosted protease inhibitor. All subjects will receive the addition of Enfurvitide administered 90 mg twice a day SQ for 12 weeks to their pre-entry regimen to determine if treatment intensification with this agent can lead to the achievement and maintenance of viral suppression below 20 copies/mL after Enfurvitide therapy is withdrawn. Subjects with continued low level viremia despite 12 weeks of enfurvitide will be offered an additional 12 weeks of the medication.