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New Clinical Trial at ACTU

Study: Bone Loss in People With HIV

March 26, 2004

The study is a Phase II, randomized, double-blinded, placebo-controlled study of once-weekly Alendronate in HIV-infected subjects with decreased bone mineral density receiving calcium and vitamin D. (Alendronate is an FDA-approved drug to treat osteoporosis. Its use in this study is experimental.)


Eligibility

  • Men and women 25 years or older (This study is almost full for male subjects, and the ACTU is focusing on screening women for this study.)

  • DEXA scan (a special X-ray to measure body composition) showing decreased bone mineral density

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  • CD4 count of 100 or higher

  • Viral load of 5000 or less

  • No hepatitis C infection

  • Currently taking stable HIV medications for at least 12 weeks

  • Must not have had any bone fractures in the past 6 months


Treatment

The study will provide the following combinations:

  • Group 1. Alendronate plus a calcium/vitamin D supplement

  • Group 2. Alendronate placebo (no active drug) plus a calcium/vitamin D supplement. The use of alendronate in the study is investigational.


Compensation

Exams, lab tests, and study medications at no cost. $20 per study visit and $25 for each DEXA scan while on study. Contact the ACTU (206) 731-3184 and ask for the screening nurse on call.

To see a complete list of clinical trials at the ACTU visit our Web site at http://depts.washington.edu/actu or call (206) 731-3497 and ask for the Outreach Coordinator, Joaquin Perez or Alyssa Spingola RN at (206) 731-8876.




  
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This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Ezine.
 
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