Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth

Cornell University

Status: Completed

Conditions: Malnutrition; HIV; Cachexia; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT01647841

IRB 1111002615

Details and patient eligibility

About

The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of northern Tanzania affect fetal growth, pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.

Enrollment: 218 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed consent provided by mothers, and parental consent on behalf of their infants
• Confirmed HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
• Estimated gestational age between 12th and 34th weeks
• Stated intention to remain in the clinic catchment area ≥6 months post-partum
• Singleton birth

Exclusion criteria

• None

Trial design

218 participants in 1 patient group

Pregnant women and infants

Description:

HIV+ and HIV- pregnant women, HIV-exposed and HIV-unexposed infants, ARV-exposed and ARV-unexposed infants