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Anti-HIV gel being evaluated in pregnant and breastfeeding women
Date:6/20/2011

ctive drug in the mother's bloodstream, and in the amniotic fluid and umbilical cord blood. The drug levels measured in umbilical cord blood were 40 times lower than drug levels in studies of HIV-infected women who took the tablet form of tenofovir while they were pregnant. Building on these results, MTN-008 will test daily use of tenofovir gel by pregnant women for one week during third trimester pregnancy, and daily use of the gel for one week by breastfeeding mothers four to 26 weeks after they have given birth.

"By taking a cautious, step-wise approach to this research, we are ensuring the safety of both mothers and their infants," said Dr. Beigi. "Our overall goal is to find a product that women can safely use to protect against HIV during all stages of pregnancy and motherhood."

Researchers will enroll approximately 105 HIV-negative mother-infant pairs. For the pregnancy group, researchers will initially enroll 45 women between 37 and 39 weeks gestation and randomize them to receive tenofovir gel or a placebo gel. The women will apply one dose of their assigned study product (tenofovir gel or placebo gel) for seven consecutive days and undergo evaluation for side effects. Provided there are no safety concerns, researchers will then enroll a second group of 45 pregnant women who will follow the same seven-day regimen. The second group of women will enter the study earlier in their third trimester -- between 34 and 36 weeks gestation. For the group of breastfeeding women, all 15 participants who are enrolled will use tenofovir gel daily for seven days.

The researchers plan to evaluate the safety of the drug and assess how much active drug is absorbed during pregnancy and subsequently transferred to the fetus. In breastfeeding mothers, the researchers will also measure drug levels in breast milk and assess whether the drug is transferred to the baby. Depending on results of the study, which are expected in late 2012, the re
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Contact: Clare Collins
collcx@upmc.edu
412-641-7299
Microbicide Trials Network
Source:Eurekalert

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