A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Three Different Potent Regimens in HIV-Infected Women… Between 28 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission (P1081, Version 2.0)

Service: Trial Number:
109-12
Principal Investigator: Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes

A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Three Different Potent Regimens in HIV-Infected Women Initiating Triple Antiretroviral Regimens Between 28 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission (P1081, Version 2.0). The current strategy for the prevention of mother to child transmission (PMTCT) are based on 1) the use of three medications against HIV (antiretrovirals or ARV) after the first trimester through labor, 2) appropriate management of delivery, and 3) avoidance of breastfeeding. These interventions have successfully reduced the rates of HIV transmission from an HIV positive mother to her child to less than 2%. There is additional evidence that being on triple ARV treatment at conception and starting earlier in pregnancy were associated with a lower risk of transmission. However, this strategy is highly dependent on early access to prenatal care, the availability of ARV and appropriate method of delivery. Many pregnant women enter into prenatal care after the 28th week of gestation even in developed countries. The aim of this study is to compare the safety, tolerability of three ARV classes in HIV-infected pregnant women presenting late for care. It will also compare how the drug is handled by the body, how well it reduces the amount of virus in the blood and its effect on the immune system. The study will enroll HIV-1 infected pregnant women with gestational age 28-36 weeks who have either never been treated for HIV or have only received treatment with short-course zidovudine (maximum of 8 weeks) for prevention of MTCT in previous pregnancies, and their infants. Women and infants will be followed for 6 months after delivery to monitor for toxicity and infant HIV transmission.

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