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

NCT ID: NCT07052409

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2029-07-31

Brief 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.

Detailed Description

1. The study will enroll 24 pregnant women with HIV at 36 weeks gestational age and randomize them 1:1 to receive 500 ml daily of pasteurized fermented milk (Inkomasi) or not. Changes in maternal gut microbiota from enrollment to 2-4 weeks postpartum will be compared between groups. The study will also compare the gut microbiome at infants born to mothers who received Inkomasi with those born to mothers who did not receive Inkomasi.

2. The study will enroll 24 HIV-exposed uninfected infants (HEU) at 24 weeks of age and randomize them 1:1 to receive ≥15 ml daily of pasteurized fermented milk (Inkomasi) or not. Changes in infant gut microbiota from enrollment to 4 weeks after enrollment will be compared between groups.

Conditions

Gut Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Inkomasi

Diet supplementation with pasteurized fermented milk

Group Type: ACTIVE_COMPARATOR

Inkomazi

Intervention Type: DIETARY_SUPPLEMENT

Pasteurized fermented milk

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inkomazi

Pasteurized fermented milk

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Pregnant women with HIV HIV-exposed uninfected infants

Exclusion Criteria

-

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Adriana Weinberg

Professor of Pediatrics, Medicine and Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriana Weinberg, MD

Role: PRINCIPAL_INVESTIGATOR

AMC UCD

Locations

Witwatersrand

Johannesburg, , South Africa

Countries

South Africa

Other Identifiers

24-1383 COMIRB

Identifier Type: -

Identifier Source: org_study_id