Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission. The one drug standard treatment and two combinations to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3) zidovudine/lamivudine/nelfinavir.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Lamivudine; Nelfinavir; Nevirapine; Zidovudine

Criteria

Inclusion Criteria:

Infants who meet all of the following criteria are eligible for the study:

• Mother known to be HIV-1-infected prior to labor or identified at the time of labor or <48 hours postpartum. HIV-1 infection for the purposes of enrollment into this study is defined as: (a) Single positive HIV-1 rapid test in mother or her infant; or (b) Historical documentation of a positive HIV-1 diagnostic test confirmed by repeat diagnostic testing for HIV-1 according to country guidelines in mother (written documentation of test results must be present in the medical record).

• Maternal written informed consent for study participation.

• Mother has not received any antiretroviral therapy during the current pregnancy prior to the onset of labor and delivery; women may have received intravenous or oral ZDV during labor. Women may have received any antiretroviral therapy in previous pregnancies for prevention of vertical HIV-1 transmission.

• Infant is <48 hours old. Infant may have received up to 48 hours of ZDV as standard care before study enrollment.

Exclusion Criteria:

Infants who meet any of the following criteria will be excluded from the study:

• Extreme prematurity (< 32 weeks of gestation).

• Birth weight <1500 grams.

• Presence of life-threatening conditions.

• Inability to take oral medication throughout the first 48 hours of life (must be able to receive oral medication by age 48 hours).

• Maternal inability to provide informed consent because of a lack of a conscious state, psychiatric conditions, or language barriers.

• Mother received any antiretroviral therapy during labor and delivery other than intravenous or oral ZDV.