PACTG 1021:

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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. The use of different anitretrovial agents in combination drug therapy regimens is the current state of the art for mangement of HIV-infected subjects. These regimens combine different antiviral targets, which are expected to increase the efficacy, decrease the toxicity and delay the development of resistance of the individual drugs. The anticipated synergistic effect produced by drug combination therapy is one of the primary objectives for evaluation in this study. The once daily pediatric dose regimen of FTC that will be used in PACTG P1021 is supported by data from a Phase I single-dose trial in HIV-infected or exposed pediatric subjects less than 18 years of age. The selection of a once daily dosing approach was based on the recently published data for the ANRS clinical trial in France, which was previously discussed (2,4,5,6). The difficulty in assuring adherence with current regimens requiring multiple daily doses is well recognized as a major barrier to effective antiretroviral therapy. A once daily regimen offers both advantage for pediatric subjects and their caregivers.