ANTIRETROVIRAL THERAPY FOR HIV-INFECTED ADULTS PRESENTING WITH ACUTE

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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 in HIV-1 infected subjects with acute opportunistic infections (OIs) or pneumonia is being conducted to define the optimal timing for initiating antiretroviral (ARV) therapy in this population. Subjects will be randomized to receive ARV within the first two weeks after starting acute OI therapy or have ARV therapy differed between four and thirty-two weeks. Subjects will be followed through 48 weeks. Approximately 282 subjects will enroll nationally with five to ten enrolled locally. The primary endpoint will be a combined endpoint of survival, virologic control, and AIDS progression. Success of OI treatment will be evaluated by duration of hospitalization, complication rates, adverse events, and serious toxicities occurring during treatment. A pharmacokinetic substudy will determine the pharmacokinetic profile of lopinavir/ritonavir during an acute OI/pneumonia phase.