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About The Study
To determine if therapeutic supplementation with mixed carotenoids 120,000 IU (USANA Pharmaceuticals, Inc.) plus daily multivitamin can increase survival in patients with AIDS, or prolong time to new or recurrent AIDS defining illness.
Study Approach
Using a randomized double blind study design, HIV positive volunteers with advanced AIDS were placed in either a mixed carotenoid and multi-vitamin group, or a multivitamin alone group, over a background of specific anti-HIV therapy.
Study population
The trial enrolled 331 HIV+ patients with severe advanced immune disease.
Results
Due to pharmaceutical instability of the carotene component of the study medication, the study was terminated on May 1, 1999, and all available data were collected and analysed. Baseline characteristics were similar between treatment arms. 40 patients (12.1%) have final status outstanding. Serum carotene levels were higher in the mixed carotenoid group at all follow-ups (p<0.001). Log baseline serum carotene level was a significant univariate predictor of death (p=0.009) and a similar trend existed for AIDS or death (p<0.10). There was a trend for improved outcome in the carotenoid group compared to control; 12 deaths versus 23 (log-rank p=0.06); 24 patients with an AIDS diagnosis or death versus 36 (log-rank p=0.15). Similar results were observed with multivariate analysis.
Conclusions
Overall, the study suggests that mixed carotenoids may be important and beneficial for this population. Since the results are not definitive, further studies should be done. The observation that a low serum carotene level, which may be influenced by many factors, is a predictor of outcome is of great interest.