NCT02369406

Early Infant HIV Treatment in Botswana

BHP Early Infant Treatment Study: A Clinical Treatment Trial of HIV+ Infants in Botswana

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 0 Days – 3 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to determine whether very early antiretroviral treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and maintains immune responses, potentially allowing future periods off ART.

Detailed description

HIV-1 infection during adulthood leads to a stable, long-lasting viral reservoir in CD4 T cells that persists despite suppressive antiretroviral therapy (ART), and is responsible for rapid viral rebound once treatment is stopped in most cases. In neonates, HIV-1 infection occurs at a time when the adaptive immune system is still in development, which may alter the establishment of a long-lasting viral reservoir and offer opportunities to reduce viral persistence through early antiretroviral treatment. Recently, scientific understanding of neonatal HIV infection has been challenged by the description of an infant who tested positive for HIV at birth, was treated with potent combination antiretroviral therapy (ART) within the first 30 hours of life, and achieved long-term remission of HIV infection when ART was stopped approximately 18 months later. Unfortunately, after 2 years off ART, rebound viremia occurred in this child, yet this case raises the provocative question of whether ART initiated within the first days of life for an antepartum infection, or in the first days/weeks of life for a peripartum infection, can prevent the seeding of a long-lasting reservoir of HIV infected cells in some infants (and therefore lead to long periods of HIV remission off ART).

Conditions

• HIV
• Pediatric AIDS

Interventions

Type	Name	Description
DRUG	Nevirapine
DRUG	Kaletra
DRUG	Lamivudine
DRUG	Zidovudine

Timeline

• Start date: 2015-05-04
• Primary completion: 2020-11-06
• Completion: 2029-06-30
• First posted: 2015-02-24
• Last updated: 2026-02-23

Locations

1 site across 1 country: Botswana