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Early Infant HIV Treatment in Botswana

NCT02369406 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

  • HIV
  • Pediatric AIDS

Interventions

DRUG

Nevirapine

DRUG

Kaletra

DRUG

Lamivudine

DRUG

Zidovudine

Sponsors & Collaborators

  • Ragon Institute of MGH, MIT and Harvard

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Botswana Harvard Health Partnership

    collaborator UNKNOWN

  • University of California, San Diego

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

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

  • Daniel R. Kuritzkes, MD · Brigham and Women's Hospital

  • Mathias Lichterfeld, MD, PhD · Ragon Institute of MGH, MIT and Harvard

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-04
Primary Completion
2020-11-06
Completion
2029-06-30

Countries

  • Botswana

Study Locations

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Entities

Diseases
Companies

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 NCT02369406 on ClinicalTrials.gov