This study will investigate the effect of antiretroviral therapy (ART) on pregnant women and their infants using two experimental laboratory tests. The first test is for mitochondrial DNA (mtDNA) and will examine the level of function of the mitochondria. The second test will look at the damage the drugs may do to the length of DNA at the end of chromosomes (telomeres). In addition, the study aims to better understand the relationship between preterm birth, HIV, ART, the bacterial environment of the vagina, and other risk factors for preterm birth.
ART reduces the chance of HIV transmission from mother to child from 25% to less than 1%, but some anti-HIV drugs may have a toxic effect on the cells of the body.
Research has shown that pregnant women living with HIV are twice as likely to have a preterm delivery compared to a pregnant woman without HIV. Because preterm delivery is a complicated condition with several possible contributing factors, it is unclear if HIV, ART, and the bacterial environment of the vagina have an effect.
This study consists of 3 study visits during pregnancy, generally between weeks 16-20, 24-28, and 32-36. Two additional visits will be scheduled during the time of delivery as well as 4-8 weeks following delivery. Blood samples will be drawn at these same visit times, umbilical cord blood will be collected at the time of delivery, and a small piece of cord tissue and placenta will be collected, if possible. A self-collected vaginal swab will be used to assess the types of bacteria in the vagina at each visit. At delivery, and if there is any threat of preterm delivery, the attending doctor will gather additional swabs during the physical exam. Swabs and blood samples will be collected periodically from the baby for 8 weeks following birth.
If you would like more information on this clinical study, please refer to one of the investigators.
University of British Columbia Vancouver, BC
Université de Montréal Montréal, QC
University of Saskatchewan Saskatchewan, SK