A randomized trial of multivitamin supplements and HIV disease progression and mortality.
BACKGROUND
Results from observational studies suggest that micronutrient status is a determinant of the progression of human immunodeficiency virus (HIV) disease.


METHODS
We enrolled 1078 pregnant women infected with HIV in a double-blind, placebo-controlled trial in Dar es Salaam, Tanzania, to examine the effects of daily supplements of vitamin A (preformed vitamin A and beta carotene), multivitamins (vitamins B, C, and E), or both on progression of HIV disease, using survival models. The median follow-up with respect to survival was 71 months (interquartile range, 46 to 80).


RESULTS
Of 271 women who received multivitamins, 67 had progression to World Health Organization (WHO) stage 4 disease or died--the primary outcome--as compared with 83 of 267 women who received placebo (24.7 percent vs. 31.1 percent; relative risk, 0.71; 95 percent confidence interval, 0.51 to 0.98; P=0.04). This regimen was also associated with reductions in the relative risk of death related to the acquired immunodeficiency syndrome (0.73; 95 percent confidence interval, 0.51 to 1.04; P=0.09), progression to WHO stage 4 (0.50; 95 percent confidence interval, 0.28 to 0.90; P=0.02), or progression to stage 3 or higher (0.72; 95 percent confidence interval, 0.58 to 0.90; P=0.003). Multivitamins also resulted in significantly higher CD4+ and CD8+ cell counts and significantly lower viral loads. The effects of receiving vitamin A alone were smaller and for the most part not significantly different from those produced by placebo. Adding vitamin A to the multivitamin regimen reduced the benefit with regard to some of the end points examined.


CONCLUSIONS
Multivitamin supplements delay the progression of HIV disease and provide an effective, low-cost means of delaying the initiation of antiretroviral therapy in HIV-infected women.
Fawzi
Wafaie W
WW
Department of Nutrition, Harvard School of Public Health, Boston, MA 02115, USA. mina@hsph.harvard.edu
Msamanga
Gernard I
GI
Spiegelman
Donna
D
Wei
Ruilan
R
Kapiga
Saidi
S
Villamor
Eduardo
E
Mwakagile
Davis
D
Mugusi
Ferdinand
F
Hertzmark
Ellen
E
Essex
Max
M
Hunter
David J
DJ
D017088:AIDS-Related Opportunistic Infections / Q000517:prevention & control; D000328:Adult; D018791:CD4 Lymphocyte Count; D019587:Dietary Supplements; D018450:Disease Progression; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality / Q000635:transmission; D006801:Humans; D018445:Infectious Disease Transmission, Vertical; D018977:Micronutrients / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D013636:Tanzania / Q000453:epidemiology; D019562:Viral Load; D014801:Vitamin A / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D014815:Vitamins / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
D018977:Micronutrients; D014815:Vitamins; D014801:Vitamin A