ADULTS AIDS CLINICAL TRIALS UNIT UPR ADULT ACTU

成人艾滋病临床试验单位 UPR 成人 ACTU

• 批准号: 6699373
• 负责人: Jorge Santana
• 金额: $ 156.21万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-01-01 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6699373
• 关键词: AIDS; AIDS /HIV neuropathy; AIDS related neoplasm /cancer; AIDS therapy; HIV infections; Histoplasma; Mycobacterium avium; Mycobacterium tuberculosis; Pneumocystis pneumonia; antiAIDS agent; antiviral antibody; body composition; cardiovascular disorder; cardiovascular disorder prevention; clinical research; clinical trial phase I; cooperative study; cytomegalovirus; drug adverse effect; drug interactions; experimental designs; gender difference; glucose metabolism; hepatitis B virus group; hepatitis C virus; human immunodeficiency virus 1; human subject; human therapy evaluation; hydroxyurea; immunoregulation; immunotherapy; latent virus infection; lipid metabolism; longitudinal human study; nucleoside analog; nucleotide analog; nutrition; opportunistic infections; outcomes research; pathologic process; pharmacokinetics; prodrugs; protease inhibitor; statistics /biometry; therapy compliance

DESCRIPTION (adapted from applicant's abstract): The University of Puerto Rico (UPR) ACTU Unit has accrued significant numbers of patients for several important clinical trials and has developed an infrastructure group. In the last 36 months, the UPR Adult ACTU has participated in 18 different ACTG trials. A total of 231 new patients have been accrued to participate in studies and sub-studies. All of the patients are Hispanics and are stratified as follows: 36 percent females, 65 percent males, 21.6 percent Injection Drug Users (IDU). The UPR Adult ACTU plans for immediate research in collaboration with the Pharmacy Research Section to perform Phase I and II pharmacokinetic (PK) and intracellular concentration trials, as well as clinical trials in naive and heavily pre-treated individuals, women and IDUs. They will embark in such important aspects of metabolic complications and novel approaches with immunological enhancers, among others. The UPR ACTU, as a part of the ACTG, offers an opportunity to study variation patterns in the epidemiological and clinical manifestations of AIDS in minority groups. It also provides for much needed supportive and therapeutic alternatives to patients.

描述（改编自申请人摘要）：波多黎各大学 (UPR)ACTU单位已经积累了大量的病人， 重要的临床试验，并建立了一个基础设施小组。 在 过去36个月，普遍定期审议成人行动小组参加了18个不同的行动小组， 审判 共有231名新患者参加了 研究和子研究。 所有患者均为西班牙裔， 女性占36%，男性占65%，注射毒品占21.6%， 用户（IDU）。 普遍定期审议成人ACTU计划立即合作研究 与药学研究部门一起进行I期和II期药代动力学研究 (PK)和细胞内浓度试验，以及临床试验， 天真的和大量预先治疗的个人，妇女和注射吸毒者。他们将登上 代谢并发症和新方法的重要方面， 免疫增强剂等。 普遍定期审议行动联盟作为咨询小组的一部分， 提供了一个研究流行病学变化模式的机会， 少数民族艾滋病的临床表现。 它还提供了许多 需要支持和治疗的替代方案。