Study to Improve Survival Among HIV-Exposed Infants in Botswana

Summary

The purpose of this study is to find ways to improve infant health and survival among infants whose mothers are HIV-infected but who do not themselves have HIV.

Conditions

• HIV Infections
• Neutropenia
• Anemia

Interventions

DRUG

cotrimoxazole prophylaxis

100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months

DRUG

cotrimoxazole placebo

100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months

BEHAVIORAL

exclusive breastfeeding until 6 months of age

Breastfeeding for 6 months, followed by formula feeding for 6 month. Breastfeeding infants will be prophylaxed with maternal highly active antiretroviral therapy (HAART) (if available) or with infant nevirapine.

BEHAVIORAL

breastfeeding for 12 months

Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Shahin Lockman, MD, MS · Harvard School of Public Health (HSPH)

• Roger L Shapiro, MD, MPH · Harvard School of Public Health (HSPH)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2015-03-31

Completion

2018-10-31

Countries

• Botswana

Study Locations