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The purpose of this study is to better understand the relationship between age and HIV disease progression.
This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.
Older age is an important risk factor for accelerated HIV-disease progression. However, the virologic response to highly active antiretroviral therapy (HAART) may be superior in older persons. A better understanding of the immunologic, virologic, and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease.
Patients are grouped according to age. Group A consists of patients between the ages of 13 and 30 years. Group B consists of patients age 45 years or older. All patients receive open-label lopinavir/ritonavir (LPV/RTV) plus emtricitabine (FTC) plus stavudine (d4T) for 96 [AS PER AMENDMENT 06/04/02: 192] weeks. Study visits occur at pre-entry, entry, and Weeks 4, 8, 12, 16, and 24 then every 12 weeks thereafter through Week 96 [AS PER AMENDMENT 06/04/02: Week 192]. Clinical assessments, safety laboratory tests, CD4 cell count monitoring, lymphocyte phenotyping, and HIV-1 RNA determinations are performed routinely. Blood samples are stored for further immunology and virology studies. Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s [AS PER AMENDMENT 06/04/02: Substudy A5017s has been eliminated.]
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Lopinavir/Ritonavir, Emtricitabine, Stavudine
Univ of Southern California / LA County USC Med Ctr
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-27T03:57:29-0400
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AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...