CTN 238: The MAINTAIN study

 

A randomized control clinical trial of micronutrient and antioxidant supplementation in persons with untreated HIV infection

About the study

This study will examine if supplementation of a specially enhanced micronutrient preparation, compared to standard vitamins, can slow disease progression or delay the start of ARVs in asymptomatic adults currently not needing nor taking ARVs. Researchers will examine the safety and effect of the supplement on participants’ health and well-being over two years. This is a three-year study recruiting 218 participants from The Ottawa Hospital and participating CTN sites.

Participants will be randomly assigned to one of the two following equal groups:
• Group A (experimental arm): Participants will receive an oral micronutrient antioxidant preparation daily (K-PAX Ultra®)
• Group B (control arm): Participants will receive identical appearing standard multivitamins (Centrum-like)

Study Approach

Each group will take 8 capsules twice daily with food. Neither the participant nor the doctor will know which treatment is being administered.
Though the role of supplementation remains unclear, some studies show that supplementation of micronutrient antioxidants may help protect an individual’s immunity and health. This is important because even in the early stage of HIV infection, persons commonly experience lower blood levels of micronutrients (vitamins and minerals) which may increase the risk of disease progression to AIDS.

Participating Sites

Alberta, British Columbia, Manitoba, Nova Scotia, Ontario,Newfoundland, Quebec