Read JS, Mofenson L, Bethel J, Moye J, Meyer W, Nugent R, Korelitz J, Rich K, Pahwa S; International Conference on AIDS.

Int Conf AIDS. 1996 Jul 7-12; 11: 109 (abstract no. Mo.B.1317).

PAMA - CRMC - NICHD, National Institutes of Health, Bethesda, MD, USA. Fax: (301) 496-8678. E-mail: ReadJ@hd01.nichd.nih.gov.

Objective: To describe changes in serum Vitamin A levels over time in HIV-infected children in the U.S. enrolled in the NICHD IVIG Clinical Trial (NEJM 1991;325:73). To investigate whether Vitamin A deficiency is associated with increased mortality because of the previously reported association between Vitamin A deficiency and mortality in HIV-infected children. Methods: Blood was collected for central repository storage at entry and at 3 month intervals during the trial. Ultra-frozen serum specimens from children with greater than or equal to3 samples were hexane-extracted and assayed by HPLC. Changes over time were analyzed by calculating the difference (final-initial log10 values) and slope (average yearly log10 rate of change) within each subject. Results: Serum Vitamin A (mg/l) was measured in 706 samples from 141 subjects (65 from IVIG group and 76 from placebo group). The mean (standard error) initial values for the IVIG and placebo groups were similar (0.32 (0.01) versus 0.32 (0.02), p = 0.83). There was a significant change in Vitamin A levels during the study period for the IVIG group as measured by their mean difference (+0.046, p = 0.03) and slope (+0.049, p = 0.05), but the change was not significant for the placebo group (difference = -0.024, p = 0.38; slope = +0.009, p=0.79). In multivariate analysis controlling for time on study, AZT, TMP/SMX, age, and entry CD4 +, the difference was significantly greater in the IVIG group than in the placebo group (p = 0.03), but not the slope (p = 0.35). Mortality did not vary significantly by quartile of difference (10.8%, 11.8%, 2.9%, 17.1%; p = 0.67), by quartile of slope (13.9%, 5.7%, 2.9%, 20.0%; p = 0.52), or by quartile of initial level (8.1%, 12.2%, 6.7%, 15.2%; p = 0.50). Conclusions: Serum vitamin A levels increased over time in the IVIG treatment group. Overall mortality was not consistently associated with initial levels or subsequent changes in Vitamin A.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• CD4 Lymphocyte Count
• Child
• Clinical Trials as Topic
• HIV Infections
• HIV Seropositivity
• Hematologic Tests
• Humans
• Immunoglobulins, Intravenous
• United States
• Vitamin A
• Vitamin A Deficiency
• Zidovudine

Other ID:

• 96921381

UI: 102217280

From Meeting Abstracts