Design and methods of the MAINTAIN study: a randomized controlled clinical trial of micronutrient and antioxidant supplementation in untreated HIV infection.
Micronutrient deficiencies are common in HIV positive persons and are associated with a poorer prognosis, but the role of micronutrient supplementation in the medical management of HIV infection remains controversial, as some but not all studies show immunological and clinical benefit. Micronutrients supplementation could be a relatively low cost strategy to defer the initiation of expensive, potentially toxic and lifelong antiretroviral therapy. The MAINTAIN study is a Canadian multi-center randomized control double blind clinical trial to evaluate if micronutrient supplementation of HIV positive persons slows progression of immune deficiency and delays the need to start antiretroviral therapy and is safe, compared to standard multivitamins. Untreated asymptomatic HIV positive adults will receive a micronutrient and antioxidant preparation (n = 109) or an identical appearing recommended daily allowance multivitamin and mineral preparation (n = 109) for two years. Participants will be followed quarterly and monitored for time from baseline to CD4 T lymphocyte count <350 mm(3), or emergence of CDC-defined AIDS-defining illness, or the start of antiretroviral therapy. We will also compare safety and health related quality of life between groups. Primary analysis will compare the incidence of the composite primary outcome between study groups and will be by intention-to-treat. The study was originally expected to last three years, with accrual over one year and a minimum of two years follow up of the last enrolled participant. We discuss here the study design and methods, often used for evaluation of complementary and adjunctive treatments for health maintenance in HIV infection, which are common interventions.
Singhal
Neera
N
Department of Medicine, University of Ottawa at Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. nsinghal@ohri.ca
Fergusson
Dean
D
Huff
Harold
H
Mills
Edward J
EJ
la Porte
Charles
C
Walmsley
Sharon
S
Cameron
D William
DW
D000328:Adult; D000975:Antioxidants / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002170:Canada; D019587:Dietary Supplements; D004311:Double-Blind Method; D015658:HIV Infections / Q000628:therapy*; D006801:Humans; D055118:Medication Adherence; D018977:Micronutrients / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D018401:Sample Size; D015983:Selection Bias
D000975:Antioxidants; D018977:Micronutrients