Doctoral Degrees (Biostatistics)

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    Randomised placebo-controlled trial to evaluate the effect of vitamin A on mother-to-child transmission of HIV-1 in Bloemfontein
    (University of the Free State, 2002-11) Chikobvu, Perpetual; Joubert, G.; Schall, R.; Van der Ryst, E.
    English: Mother-to-child (vertical) transmission is the primary means by which young children acquire human immunodeficiency virus type 1 (HIV -1) infection. Anti-retrovirals such as Zidovudine and nevirapine can reduce vertical transmission of HIV significantly, but this treatment is still largely unaffordable in Africa. Maternal vitamin A deficiency is suspected to enhance vertical transmission of HIV. Furthermore, vitamin A is known to act as a coenzyme to the immune process. Therefore, a double-blind randomized placebo controlled trial to assess the effect of vitamin A supplementation on vertical transmission of HIV was launched in Bloemfontein in 1997. A total of 2949 pregnant women attending the antenatal clinics at Pelonomi and Universitas hospitals and the Mangaung University Community Partnership clinic were counselled for HIV testing, and 2543 were willing to be screened by HIV testing for possible inclusion in the trial. Of the women screened 595 (23.4%) were HIV positive, and 303 of these were willing to participate in the trial. 152 women were randomized to vitamin A treatment and 151 to placebo treatment. Patients were seen at 2 monthly intervals in the antenatal phase. Post-natally mother-infants pairs were seen when the infant was 1 month old, 3 months old, and thereafter, 3 monthly till 18 months old. A total of 191 patients (63% of all the study participants) missed one or more visits and had to be traced. Of the 303 patients included in the study 158 had a conclusive infant HIV test result (patients in the Intention To Treat (!TT) analysis population) and 104 patients had a conclusive infant mv test result when the baby was 3 months old (patients in the Per Protocol (PP) analysis population). Of 158 patients, in the ITT population 73 were in the vitamin A group and 85 in the placebo group. Per treatment group the baseline characteristics of those in the IIT population and those who are not, did not differ significanti y. The mv transmission rates were 19.2% and 21.2% for vitamin A and placebo groups respectively (IIT population). There is no statistically significant difference in the transmission rates between vitamin A and placebo groups (p=0.76). Overall, this study provides no evidence that vitamin A is effective in reducing vertical mv-1 transmission rate. There was no statistically significant difference in the percentages of mv symptoms recorded at post delivery visit 1 through to the 18 months visit between the two treatment groups for either mothers or infants. A similar pattern was observed for the vital signs for the mothers. The full blood and T-cell counts were similar between the two treatment groups at all visits for both mothers and infants. Only 4 patients reported adverse events; these were not related to the treatment. Twenty six infants and one mother died during the study. The overall infant mortality rate was 85.8 per 1000 infant population. The infant death rates were approximately 11% in the placebo group and 6% in the vitamin A group (p=0.097). Thus, Vitamin A was associated with a reduction in infant mortality, although not statistically significant. This association may be worth further investigation as there is potential for a substantial impact.