Lopinavir/Ritonavir versus Lamivudine peri-exposure prophylaxis to prevent HIV-1 transmission by breastfeeding: the PROMISE-PEP trial Protocol ANRS 12174.

BACKGROUND: Postnatal transmission of HIV-1 through breast milk remains an unsolved challenge in many resource-poor settings where replacement feeding is not a safe alternative. WHO now recommends breastfeeding of infants born to HIV-infected mothers until 12 months of age, with either maternal highly active antiretroviral therapy (HAART) or peri-exposure prophylaxis (PEP) in infants using nevirapine. As PEP, lamivudine showed a similar efficacy and safety as nevirapine, but with an expected lower rate of resistant HIV strains emerging in infants who fail PEP, and lower restrictions for future HIV treatment. Lopinavir/ritonavir (LPV/r) is an attractive PEP candidate with presumably higher efficacy against HIV than nevirapine or lamivudine, and a higher genetic barrier to resistance selection. It showed an acceptable safety profile for the treatment of very young HIV-infected infants. The ANRS 12174 study aims to compare the risk of HIV-1 transmission during and safety of prolonged infant PEP with LPV/r (40/10 mg twice daily if 2-4 kg and 80/20 mg twice daily if >4 kg) versus Lamivudine (7,5 mg twice daily if 2-4 kg, 25 mg twice daily if 4-8 kg and 50 mg twice daily if >8 kg) from day 7 until one week after cessation of BF (maximum 50 weeks of prophylaxis) to prevent postnatal HIV-1 acquisition between 7 days and 50 weeks of age. METHODS: The ANRS 12174 study is a multinational, randomised controlled clinical trial conducted on 1,500 mother-infant pairs in Burkina Faso, South Africa, Uganda and Zambia. We will recommend exclusive breastfeeding (EBF) until 26th week of life and cessation of breastfeeding at a maximum of 49 weeks in both trial arms.HIV-uninfected infants at day 7 (± 2 days) born to HIV-1 infected mothers not eligible for HAART who choose to breastfeed their infants.The primary endpoint is the acquisition of HIV-1 (as assessed by HIV-1 DNA PCR) between day 7 and 50 weeks of age. Secondary endpoints are safety (including resistance, adverse events and growth) until 50 weeks and HIV-1-free survival until 50 weeks. DISCUSSION: This study will provide a new evidence-based intervention to support HIV-1-infected women not eligible for HAART to safely breastfeed their babies.

Use of herbal, complementary and alternative medicines among pregnant women in Makoni District, Zimbabwe / Uso de medicinas a base de hierbas, complementarias y alternativas entre mujeres embarazadas en el distrito de Makoni, Zimbabwe

Use of herbal, complementary and alternative medicines during pregnancy, labour and delivery is common in Zimbabwe. This study aimed at documenting herbal, complementary and alternative medicines used during pregnancy in Makoni District in Zimbabwe. Snowballing was used to select 66 participants which included herbalists (45.5%), traditional birth attendants (18.2%), traditional healers (15.2%), and assistant traditional healers and herbal medicine vendors (10.6% each). Pregnant women in the study areaused a total of 47 plant species from 27 families, and 14 non-plant products as herbal, complementary and alternative medicines by. A total of 26 medical cases were treated with the majority of medicinal plants and non-plant products, used to dilate or widen the birth canal (55.3%) and to augment labour or speed up the delivery process (46.8%). This study showed that herbal, complementary and alternative medicinesplay an important role in the provision of basic health care in Zimbabwe.

El uso de medicinas a base de hierbas, complementarias y alternativas durante el embarazo, el trabajo de parto y el parto es común en Zimbabwe. Este estudio tuvo como objetivo documentar las medicinas a base de hierbas, complementarias y alternativas utilizadas durante el embarazo en el distrito de Makoni en Zimbabwe. Se utilizó bola de nieve para seleccionar a 66 participantes que incluían herbolarios (45,5%), parteras tradicionales (18,2%), curanderos tradicionales (15,2%) y asistentes de curanderos tradicionales y vendedores de hierbas medicinales (10,6% cada uno). Las mujeres embarazadas en el área de estudio utilizaron un total de 47 especies de plantas de 27 familias y 14 productos no vegetales como medicinas a base de hierbas, complementarias y alternativas. Un total de 26 casos médicos fueron tratados con la mayoría de plantas medicinales y productos no vegetales, utilizados para dilatar o ensanchar el canal del parto (55,3%) y para aumentar el parto o acelerar el proceso de parto (46,8%). Este estudio mostró que las medicinas a base de hierbas, complementarias y alternativas desempeñan un papel importante en la prestación de atención médica básica en Zimbabwe.

Health Care Workers' Suggestions for Improving HIV-Related Maternal Care in South Africa: "Listen to Us".

INTRODUCTION: South Africa has the highest rate of individuals infected with HIV in the world. Women in particular are at increased risk for HIV infection and typically receive care from nurses and midwives who are on the front lines of health care policy and program implementation. The primary objective of this study was to compile and analyze suggestions generated by health care professionals on how to improve HIV-related maternal care in South Africa. This information can then be used to inform the direction of future programs across the country and beyond. METHODS: Two hundred forty-nine nurses, midwives, and nursing students enrolled in a South African university completed surveys as part of this qualitative cross-sectional study. Responses were transcribed and coded by independent researchers who met frequently to discuss and come to consensus on emerging themes. RESULTS: Four primary strategies to improve HIV-related maternal care emerged from the data. These women's health professionals suggested improving education, increasing grassroots-level participation by government officials, improving resources, and developing strategies aimed at decreasing the risk of secondary transmission of HIV. DISCUSSION: Nurses and midwives are frontline health care professionals who are in unique positions to offer feedback on how HIV-related maternal care can be improved. The identified strategies should be integrated into future programs, and human rights implications must be examined.

A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1.

To determine the efficacy and safety of 2 inexpensive and easily deliverable antiretroviral (ARV) regimens for the prevention of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) type 1 during labor and delivery, HIV-infected pregnant women were screened at 11 maternity health institutions in South Africa and were enrolled in an open-label short course ARV regimen of either nevirapine (Nvp) or multiple-dose zidovudine and lamivudine (Zdv/3TC). The overall estimated HIV-1 infection rates in 1307 infants by 8 weeks were 12.3% (95% confidence interval [CI], 9.7-15.0) for Nvp and 9.3% (95% CI, 7.0-11.6) for Zdv/3TC (P=.11). Excluding infections detected within 72 h (intrauterine), new HIV-1 infections were detected in 5.7% (95% CI, 3.7-7.8) and 3.6% (95% CI, 2.0-5.3) of infants in the Nvp and Zdv/3TC groups, respectively, in the 8 weeks after birth. There were no drug-related maternal or pediatric serious adverse events. Common complications were obstetrical for mothers (Nvp group, 24.3%; Zdv/3TC group, 26.3%) and respiratory for infants (Nvp group, 16.1%; Zdv/3TC group, 17.0%). This study further confirms the efficacy and safety of short-course ARV regimens in reducing MTCT rates in developing countries.