ACTG A5163: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ON

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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 is a multicenter trial of the Adult AIDS Clinical Trials group sponsored by the National Institutes of Health, National Institute of Allegery and Infectious Diseases, Division of AIDS. This study wil look at ways to increase bone mineral density in HIV infected people. Decreased bone marrow density (BMD) has been described in up to 50% of HIV subjects, with severe osteoporosis in up to 21%, yet the mechanisms underlying these bone abnormalities remains unclear. One way to help increase BMD is to supplement the diet with calcium and vitamin D. Another way is to take alendronate, which is an FDA approved drug (although not for this subject population) to reverse decreased BMD. This study will test whether or not alendronate will be able to reverse decreased BMD in HIV-infected subjects and how well alendronate therapy is tolerated when taken in conjunction with antiretroviral therapy, and whether calcium and vitamin D supplementation is a better treatment option for this group of subjects. Subjects will be randomized into two groups: one group will receive alendronate every week along with calcium and vitamin D supplements, the other group will receive a placebo every week along with calcium and vitamin D supplements. Subjects will have DEXA scans four times during the course of the study to evaluate whether or not alendronate is increasing their BMD. We will be asking the GCRC staff to administer the four DEXA scans in this study. The screening, entry, week 2, 12, 24, 36 and 48 visits will take place in the AIDS Clinical Trials Unit (ACTU) in G255 Mayo under the auspices of the ACTU PI and co-PI and research nurses. The ACTU research nurses will be responsible for all apsects of this study (see page 36 of the protocol entitled "6.0 Clinical and Laboratory Evaluations".