PACTG 1020-A (VERSION 20):PHASE I/II STUDY OF A NOVEL PROTEASE INHIBITOR 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. The past years have been marked by substantial progress in accomplishing the current agenda of the PACTG and in planning for the future to meet the challenges of HIV infected pregnant women, children and adolescents. In particular, the PACTG has significantly broadened its response to meet the challenges of treating and preventing HIV/AIDS in the developing world. Of the approximately 42 million persons infected with HIV worldwide, more than 3 million are children. Of the 16,000 new infections daily, 2,000 are in children below 15 years and 50% are in youth between 15 and 25 years. More than half of new HIV infections occur in women. Within the U.S., perinatal infection of children has been altered from an invariably fatal disease to a chronic illness with <1% annual mortality of children followed in PACTG 219c over the past 6 years. Additionally, in the U.S., 50% of new infections (~20,000) occur in youth between 13 and 25 years of age, and more HIV-infected women are giving birth to second and third children than ever before. Although 95% of new infections occur in developing countries, the world looks to the PACTG for guidance and leadership in helping to set a course that will control and treat, and one day prevent and cure HIV infection. Despite the increased emphasis on international HIV treatment and prevention, the importance of the PACTG domestic sites, and the role that domestic HIV research plays in providing leadership to the international community cannot be overemphasized. In fact, almost every international clinical trials program currently works either directly through PACTG involvement or indirectly through tapping the expertise of individuals who work closely with the PACTG in their programs designed to prevent perinatal transmission of HIV, and to improve treatments for HIV-infected children and adolescents. A strong and innovative domestic PACTG forms the foundation from which to build and sustain international clinical trials sites. In 2004, 1,424 subjects were newly accrued into PACTG trials and a total of 5,226 subjects were actively followed in PACTG studies.