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HIV-infected infants appear to have an increased risk of adverse effects following Bacillus Calmette-Guerin (BCG) vaccination, which may be due to higher-than-recommended vaccine doses. The BCG vaccine is used to prevent tuberculosis. Researchers followed 291 infants who received the BCG vaccine at birth. Of these, 125 infants were born to HIV-infected mothers. At the 15-month follow-up, mild or moderate complications had developed in 9.6% of the children born to uninfected mothers, 30.8% of HIV-infected infants, and 13.3% of uninfected infants born to HIV-infected mothers. None of the children developed severe complications. Some children had received at least twice the recommended vaccine dosage of .05 milliliters. When the correct dose was administered, the rate of complications was similar among HIV-infected children and the other children., Objective. To compare the risk of complications following Bacillus Calmette-Guerin (BCG) vaccination among children by maternal and infant HIV-1 infection status as part of an investigation of an outbreak of BCG complications. Methods. A nonconcurrent cohort study of BCG complications among 125 infants born to HIV-1 seropositive and 166 infants born to HIV-1 seronegative mothers was conducted in Cite Soleil, Haiti. Infants were examined at regular intervals until 15 months of age, and complications from BCG were documented. An investigation of BCG vaccination practices was conducted. Results. Mild or moderate complications occurred among 16 of 166 (9.6%) infants born to HIV-1 seronegative mothers compared with 4 of 13 HIV-1-infected infants (30.8%, P = .04) and 10 of 75 (13.3%, P = .39) uninfected infants born to HIV-1-infected mothers. No serious complications were noted. The outbreak of complications was associated with administration of 2.0 to 2.5 times the recommended dose of BCG vaccine. Conclusions. This and five other cohort studies indicate that there may be a small increased risk of complications following BCG vaccination among HIV-1-infected children, but the reactions are usually mild and the risk does not outweigh the benefits of BCG vaccination in populations at high risk of tuberculosis during infancy and childhood. Pediatrics 1995;95:414-418; Bacillus Calmette-Guerin, BCG, HIV, adverse events, vaccine, tuberculosis, lymphadenitis., The World Health Organization (WHO) recommends Bacillus Calmette-Guerin (BCG) vaccination for infants born in countries with a high incidence of Mycobacterium tuberculosis infection and disease.[1] Since BCG is a live [...]

This article presents a study of the cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. The global scale of the AIDS pandemic has generated a complex research agenda with challenging problems related to practical aspects of study design, cultural sensitivity of methods, protection of human subjects, and the ethics of conducting clinical trials within disadvantaged populations. The study focused on the conditions that would be necessary to conduct a trial of breast-feeding versus exclusive bottle-feeding among HIV seropositive mothers in order to determine the increased risk to infants of HIV transmission from breast-feeding. Understanding the factors that led to contrasting conclusions for the two studies will be instructive in our later discussion of the utility of cultural feasibility studies for AIDS and HIV clinical trials. The anticipated increased mortality in bottle fed infants during the first year of life would complicate the measurement of maternal-infant transmission.

Antibodies to herpes simplex virus type 2 (HSV-2), antibodies to hepatitis Bvirus (HBV) core antigen (anti-HBc), and VDRL antibodies (serologic evidence of syphilis) were evaluated in women known to be infected with human immunodeficiency virus type 1 (HIV-I) (n = 95) or human T Iymphotropic virus type 1 (HTLV-I) (n = 45) and controls (n = 89). HIV-I-seropositive women were more likely than controls to have antibodies to HSV-2 (88% vs. 54%; P < .001), anti-HBc (67% vs. 43%; P = .008), and VORL antibodies (21% vs. 8%; P = .02). Similarly, HTLV-I-seropositive women were more likely than controls to have antibodies to HSV-2 (82% vs. 54%; P = .003) and anti-HBc (67% vs. 43%; P = .008). There was no evidence that HIV-I or HTLV-I predisposed to chronic hepatitis B virus infection. The stronger associations between HIV-I and HTLV-I with HSV-2 than the associations with syphilis or HBV are consistent with the hypothesis that recurrent disruptions of mucous membranes caused by HSV-2 infections predispose to sexual transmission of HIV-1 and HTLV-I. [ABSTRACT FROM PUBLISHER]

HIV/AIDS has had a profound impact on children around the world since the start of the epidemic. There are currently 3.4 million children under the age of 15 years living with HIV globally, and more than 450,000 children currently receiving lifesaving antiretroviral treatment. This article describes efforts supported by the President's Emergency Plan for AIDS Relief (PEPFAR) to expand access to treatment for children living with HIV in high-burden countries. The article also highlights a series of case studies that illustrate the impact that the PEPFAR initiative has had on the pediatric HIV epidemic. Through its support of host governments and partner organizations, the PEPFAR initiative has expanded HIV testing and treatment for pregnant women to reduce vertical transmission of HIV, increased access to early infant diagnosis for HIV-exposed infants, improved training and resources for clinicians who provide pediatric care and antiretroviral treatment, and, through public-private partnerships with pharmaceutical manufacturers, helped increase the number of medications available for the treatment of HIV-infected children in resource-limited settings.

HIV-positive lactating women may be at high risk of weight loss due to increased caloric requirements and postpartum physiological weight loss. Ten percent weight loss is associated with a higher risk of mortality in HIV-positive patients and this alone is a criterion for highly active antiretroviral therapy (HAART) initiation where CD4 counts are not available. However, no study has investigated this association in lactating postpartum women. We investigated whether 10% weight loss predicts death in postpartum HIV-positive women. A total of 9207 HIV-negative and 4495 HIV-positive mothers were recruited at delivery. Women were weighed at 6 weeks, 3 months, and every 3 months thereafter for up to 24 months postpartum and data on mortality up to 2 years were collected. The median duration of breastfeeding was longer than 18 months. Among HIV-positive women, the independent predictors of ≥10% weight loss were CD4 cell count, body mass index, and household income. Mortality was up to 7.12 (95% CI 3.47-14.61) times higher in HIV-positive women with ≥10% weight loss than those without weight loss. Ten percent weight loss in postpartum lactating HIV-positive women was significantly predictive of death. Our findings suggest that 10% weight loss is an appropriate criterion for HAART initiation among postpartum breastfeeding women.

Background: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was to assess whether daily nevirapine given to breastfed infants through 6 weeks of age can decrease HIV transmission via breastfeeding., Methods: HIV-infected women breastfeeding their infants were eligible for participation. Participants were randomly assigned to receive either single-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborns after birth) or 6 week extended-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborn babies after birth plus nevirapine 5 mg daily from days 8-42 for the infant). The randomisation sequences were generated by computer at a central data coordinating centre. The primary endpoint was HIV infection at 6 months of age in infants who were HIV PCR negative at birth. Analyses were by modified intention to treat, excluding infants with missing specimens and those with indeterminate or confirmed HIV infection at birth. These studies are registered with ClinicalTrials.gov, numbers NCT00074399, NCT00061321, and NCT00639938., Findings: 2024 liveborn infants randomised in the study had at least one specimen tested before 6 months of age (1047 infants in the single-dose group and 977 infants in the extended-dose group). The modified intention-to-treat population included 986 infants in the single-dose group and 901 in the extended-dose group. At 6 months, 87 children in the single-dose group and 62 in the extended-dose group were infected with HIV (relative risk 0.80, 95% CI 0.58-1.10; p=0.16). At 6 weeks of age, 54 children in the single-dose group and 25 in the extended-dose group were HIV positive (0.54, 0.34-0.85; p=0.009). 393 infants in the single-dose group and 346 in the extended-dose group experienced grade 3 or 4 serious adverse events during the study (p=0.54)., Interpretation: Although a 6-week regimen of daily nevirapine might be associated with a reduction in the risk of HIV transmission at 6 weeks of age, the lack of a significant reduction in the primary endpoint-risk of HIV transmission at 6 months-suggests that a longer course of daily infant nevirapine to prevent HIV transmission via breast milk might be more effective where access to affordable and safe replacement feeding is not yet available and where the risks of replacement feeding are high., Funding: US National Institutes of Health; US National Institute of Allergy and Infectious Diseases; Fogarty International Center.