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NIH Rolls Out Large-Scale Study to Evaluate HIV Treatment in Pregnant Women

Perinatal HIV transmission refers to HIV transmission from mother to child during pregnancy, labor and delivery, or breastfeeding. It accounts for the majority of childhood HIV infections. Each year worldwide, an estimated 1.5 million women living with HIV give birth.

Previous NIH researches have helped pave the way for development of strategies to prevent perinatal transmission both in high-resource countries like the United States and in resource-limited settings around the world.

Now, the NIH 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.

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.

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 study will focus on 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.

The study, known as IMPAACT 2010, is a phase 3 study and will enroll 639 women who are 14 to 18 weeks pregnant, are living with HIV, and are not currently taking antiretroviral treatment.

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 women will be randomly assigned to be administered EFV/FTC/TDF, DTG/FTC/TAF, or DTG/FTC/TDF. Their infants will also be enrolled in the study and will receive local standard-of-care interventions for HIV prophylaxis following birth.

The researchers will monitor both the women and their infants for 50 weeks after delivery, and study staff will provide the women with counseling on antiretroviral medication adherence. Researchers will also closely monitor the women’s viral loads and test the infants for HIV. If an infant becomes infected during the study, investigators will provide referrals to local sources of HIV care and treatment.

Co-chair of the study Dr Shahin Lockman said: “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.  We hope that the [the 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.”

“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.”

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