Breaking News
January 23, 2019 - Parents’ mental health problems associated with reactive attachment disorder in children
January 23, 2019 - Graphene Flagship project studies impact of graphene and related materials on our health
January 23, 2019 - The connection between the Pope and contraceptive pills
January 23, 2019 - Prior dengue infection could protect children from symptomatic Zika
January 23, 2019 - VISTA checkpoint implicated in pancreatic cancer immunotherapy resistance
January 23, 2019 - The Tiny Camera That Could Revolutionize Cardiovascular Surgery
January 23, 2019 - Peptide isolated from soil fungi has antitumor and antibacterial properties
January 23, 2019 - TGen identifies polio-like virus as potential cause of Acute Flaccid Myelitis outbreak
January 23, 2019 - Migrants and refugees do not bring disease and are at greater health risk themselves says WHO
January 23, 2019 - Examing the effects of menopause in workplace
January 23, 2019 - Enemy number 1 – Air pollution and climate change top of WHO agenda
January 23, 2019 - Two Positive Phase III studies of Tafenoquine for the Radical Cure of Plasmodium vivax Malaria Published in The New England Journal of Medicine
January 23, 2019 - World Trade Center responders at increased risk for head and neck cancers
January 23, 2019 - Low-sugar diet leads to significant improvement in nonalcoholic fatty liver disease in boys
January 23, 2019 - Chaos in bodily regulation can optimize our immune system, finds study
January 23, 2019 - Short, text-based exercises can increase happiness for adults recovering from substance use disorders
January 23, 2019 - Body size may have greater influence on women’s lifespan than men
January 23, 2019 - Groundbreaking tool helps visualize neuronal activity with near-infrared light
January 23, 2019 - Holocaust survivors with PTSD and their offspring exhibit more unhealthy behavior patterns
January 23, 2019 - Scientists discover new genetic mutations causing inherited deaf-blindness
January 23, 2019 - UC team designs new naloxone-dispensing smart device
January 23, 2019 - Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP
January 23, 2019 - Brain activity shows development of visual sensitivity in autism
January 23, 2019 - Two hour gap between dinner and sleep is overrated says Japanese research
January 23, 2019 - Fear and embarrassment are causing smear test numbers to plummet
January 23, 2019 - Protein-secreting device implanted in epileptic rats reduces seizures, improves cognition
January 23, 2019 - Reintroduction project recovers current wild population of green turtle in Cayman Islands
January 23, 2019 - Cancer survivors face greater financial burden related to medical bills
January 23, 2019 - PSA screening reduces prostate cancer deaths by 30%
January 23, 2019 - LSTM receives grant to help improve health of people living in informal settlements
January 23, 2019 - Hemochromatosis Mutation Linked to Other Morbidity
January 23, 2019 - Why early diagnosis of autism should lead to early intervention
January 23, 2019 - Aspirin May Lower Stroke Risk in Women with History of Preeclampsia
January 23, 2019 - Exposure to certain chemicals may be linked to decrease in blood pressure during pregnancy
January 23, 2019 - Bowel cancer on the rise among younger Australians
January 23, 2019 - Scientists have reversed memory loss in a mouse model of Alzheimer’s
January 23, 2019 - Defective molecular master switch could lead to age-related macular degeneration
January 23, 2019 - Researchers identify how concussions may contribute to seizures
January 23, 2019 - Short interval between last meal of the day and bedtime may not affect blood glucose levels
January 23, 2019 - Still Too Many Highway Deaths Tied to Speeding
January 23, 2019 - Prenatal valproate exposure linked to increased ADHD risk
January 23, 2019 - Compound identified that may help treat heart failure
January 23, 2019 - Undiagnosed Asthma in Urban Adolescents May Be Common
January 23, 2019 - Study describes metabolism of intestinal microbiota in babies for the first time
January 22, 2019 - Study links concussions to development of epilepsy
January 22, 2019 - Specialist-led hospital bereavement service may help restrain legal action after difficult deaths
January 22, 2019 - Genetic study reveals possible new routes to treating osteoarthritis
January 22, 2019 - Blood test may detect early signs of lung-transplant rejection
January 22, 2019 - Blood marker could aid in early prediction of Alzheimer’s progression
January 22, 2019 - Orthodontic treatment does not guarantee future dental health
January 22, 2019 - Rutgers researchers discover cause of bone loss in people with joint replacements
January 22, 2019 - Diversity among rural Africans extends to their gut microbiomes
January 22, 2019 - Newly developed biological system lets cells to create self-curving cornea
January 22, 2019 - VTv Therapeutics Announces Publication of Comprehensive Data in Science Translational Medicine Detailing the Discovery and Clinical Development of TTP399, including Results of Phase 2 AGATA Study
January 22, 2019 - about one in three adults with prediabetes has arthritis
January 22, 2019 - A look at how data is democratizing health care
January 22, 2019 - Alcohol-Linked Disease Overtakes Hep C As Top Reason For Liver Transplant
January 22, 2019 - Researchers identify new genes linked with age-related macular degeneration
January 22, 2019 - MPFI researchers identify synaptic logic for connections between two brain hemispheres
January 22, 2019 - New approach to reduce toxic protein production in ALS
January 22, 2019 - New study extends our knowledge of the link between miRNAs and cancer
January 22, 2019 - Asthma, eczema are not barriers to active lifestyle in teenagers
January 22, 2019 - Genetic changes may predict likelihood of relapse in breast cancer patients
January 22, 2019 - Antiepileptic drug use by people with Alzheimer’s disease linked to accumulation of hospital days
January 22, 2019 - IUPUI researcher receives $2.85 million grant to find ways to improve bone strength
January 22, 2019 - Precision medicine can help keep astronauts healthy during deep space missions
January 22, 2019 - Detecting signs of neurodegeneration earlier and more accurately
January 22, 2019 - Mouse studies challenge ‘inhibition’ theory of autism
January 22, 2019 - SSB launches BIOSTAT RM TX single-use bioreactor for producing consistent quality cellular products
January 22, 2019 - Experimental drug can positively modify key characteristic behavior in FXS patients
January 22, 2019 - Low-Income Women Lack Menstrual Hygiene Supplies
January 22, 2019 - Better mouse model built to enable precision-medicine research for Alzheimer’s
January 22, 2019 - Molecular profiling of precancerous lung lesions could lead to early detection and new treatments
January 22, 2019 - Genetic factors influence where fat is stored in our bodies
January 22, 2019 - The Psychology Behind Sticking to Your New Year’s Resolutions
January 22, 2019 - Scientists aim to find genetic causes of developmental abnormalities in the vagina and uterus
January 22, 2019 - New survey reveals scale of preventative healthcare challenge in the UK
January 22, 2019 - Looming Global Crisis Means People’s Diets Must Change: Experts
January 22, 2019 - Excessive social media use is comparable to drug addiction
January 22, 2019 - Researchers show how mechanical stress affects bone development
NIH launches large study to compare treatments for pregnant women with HIV

NIH launches large study to compare treatments for pregnant women with HIV

image_pdfDownload PDFimage_print

The National Institutes of Health has launched a large international study to compare the safety and efficacy of three antiretroviral treatment regimens for pregnant women living with HIV and the safety of these regimens for their infants. The study will evaluate the current preferred first-line regimen for pregnant women recommended by the World Health Organization (WHO) and two regimens containing newer antiretroviral drugs that are becoming more widely used. It will provide data on the use of these newer drugs during pregnancy, helping to ensure that women living with HIV and their infants receive the best available treatments.

Each year worldwide, an estimated 1.5 million women living with HIV give birth. Previous research has clearly demonstrated that antiretroviral therapy to suppress HIV prevents perinatal HIV transmission and benefits the health of both mother and child. In the new study, investigators will compare the virologic efficacy of the three regimens by measuring the mother’s viral load (amount of HIV in the blood) at delivery. The study also will compare how the regimens affect rates of adverse pregnancy outcomes, such as preterm delivery and low infant birth weight; maternal adverse events; and infant adverse events.

“Women should have access to the best available HIV medications throughout their lives,” said Anthony S. Fauci, M.D., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “Our priority is to evaluate newer, improved antiretroviral drugs during pregnancy to identify the optimal regimens for women living with HIV and their infants.”

The first participants in the new clinical trial have begun receiving treatment at research sites in Zimbabwe. Clinical trial sites in the United States and Zimbabwe are now open for enrollment, with additional sites in Botswana, Brazil, Haiti, India, Malawi, South Africa, Tanzania, Thailand, Uganda, the United States and Zimbabwe expected to open in the coming months. The trial is supported by NIAID, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), all part of NIH. It is being conducted by theInternational Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network.

Currently, WHO recommends a regimen of three antiretroviral drugs–efavirenz (EFV), lamivudine (3TC) or emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF)–for pregnant women living with HIV in resource-limited settings. However, this regimen is not well-tolerated by or otherwise appropriate for all women. EFV has been linked to neuropsychiatric symptoms, including suicidal thoughts, as well as liver problems. TDF can cause kidney problems and loss of bone mineral density in adults, and some evidence suggests that prenatal exposure to TDF could cause bone loss in infants.

The new study will compare maternal EFV/FTC/TDF with regimens containing a newer drug, dolutegravir (DTG), and either tenofovir alafenamide (TAF), an alternative formulation of tenofovir, or TDF. The study, known as IMPAACT 2010 or VESTED (Virologic Efficacy and Safety of Antiretroviral Therapy Combinations with TAF/TDF, EFV and DTG), is co-chaired by Shahin Lockman, M.D., M.Sc., of Brigham and Women’s Hospital in the United States, and Lameck Chinula, M.B.B.S., M.Med., of the University of North Carolina Project at Kamuzu Central Hospital in Malawi.

DTG currently is included in two of the preferred first-line regimens recommended for adults living with HIV in the United States, and recently was included in WHO guidelines as an alternative first-line agent in non-pregnant adults. Advantages of DTG include once-daily dosing, a good safety profile, a high barrier to development of drug resistance and a relatively low production cost. Research so far indicates that TAF is as effective as TDF but appears to cause fewer kidney and bone side effects. Only a few studies have assessed the use of DTG in pregnancy, and minimal data are available on the safety and efficacy of TAF in pregnant women.

“Therapies for pregnant women and new mothers should be based on the best available evidence, always keeping in mind the health of the woman, her developing fetus and her newborn,” said Nahida Chakhtoura, M.D., of the Maternal and Pediatric Infectious Disease Branch at NICHD. “The results of this study will help inform optimal treatment of pregnant women living with HIV in both resource-limited and well-resourced settings.”

IMPAACT 2010, a Phase 3 study, aims to enroll 639 women who are 14 to 28 weeks into their pregnancies, are living with HIV and are not currently on antiretroviral treatment. The women will be randomly assigned to treatment with EFV/FTC/TDF, DTG/FTC/TAF or DTG/FTC/TDF. Their infants also will be enrolled in the study and will receive local standard-of-care interventions for HIV prophylaxis after birth. Mothers will be counseled on infant feeding options consistent with local standards of care, which may include breastfeeding or formula feeding.

The investigators will monitor both mother and infant for 50 weeks after delivery. Study staff will provide women with counseling on antiretroviral medication adherence, which is essential to keep HIV suppressed. The mothers’ viral loads will be closely monitored, and infants also will be tested for HIV. If an infant becomes infected with HIV during the study, investigators will provide referrals to local sources of HIV care and treatment. Throughout the study, investigators will closely monitor the health of mother and infant, including assessing the mother’s liver and kidney function and screening for anxiety and depression. Investigators also will conduct bone density scans of a subset of infants at 26 weeks of age and their mothers at 50 weeks postpartum. The study is expected to last for approximately three years.

“Limited pregnancy data for newer, better antiretroviral drugs–such as DTG and TAF–can mean that pregnant women may not receive the most effective and safest medications, and can delay the general adoption of better regimens in low-resource settings with high HIV prevalence,” said Dr. Lockman. “We hope that the VESTED trial will provide urgently needed information regarding the safety and efficacy of these newer drugs in pregnant women and their babies, so that optimal antiretroviral regimens can be offered to pregnant women and recommended for first-line treatment of adults living with HIV throughout the world.”

Source:

https://www.niaid.nih.gov/news-events/nih-begins-large-hiv-treatment-study-pregnant-women

Tagged with:

About author

Related Articles