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Developing Interventions for Protecting HIV-Exposed Uninfected Infants Against Severe Infections

NCT07052409 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-15

No results posted yet for this study

Summary

Research has shown that babies who are exposed to HIV, but are uninfected (negative HIV status), have a bigger risk of developing severe infections. There are naturally occurring organisms in the gut that may determine how the body protects itself against infections. These organisms may be different in babies who were exposed to the HIV virus in utero, compared to those who were not exposed. This study wants to see if the organisms in the gut of babies can be modified by supplementing the diet of the pregnant mother or of the baby at 6 months of age with Inkomasi (pasteurized fermented milk). The study will compare the type and amount of organisms in those who received supplementation and those who did not receive supplementation.

Conditions

  • Gut Microbiome

Interventions

DIETARY_SUPPLEMENT

Inkomazi

Pasteurized fermented milk

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Adriana Weinberg, MD · AMC UCD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2028-06-30
Completion
2029-07-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07052409 on ClinicalTrials.gov