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Completed Phase 1 Interventional

Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

ClinicalTrials.gov ID: NCT00038480

Public ClinicalTrials.gov record NCT00038480. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 11:44 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants Less Than 6 Months of Age

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.

Study identification

NCT ID
NCT00038480
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
31 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
14 Days to 6 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Sep 2007 (Actual)
Last update posted
Nov 1, 2021

Ends 2007

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland California 94609-1809 —
UCSF Pediatric AIDS CRS San Francisco California 94143-0105 —
Univ. of Colorado Denver NICHD CRS Aurora Colorado 80218-1088 —
Children's National Med. Ctr. Washington DC NICHD CRS Washington D.C. District of Columbia — —
Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida 32209 —
USF - Tampa NICHD CRS Tampa Florida — —
Chicago Children's CRS Chicago Illinois 606143394 —
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology Baltimore Maryland 21201 —
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases Baltimore Maryland 21287 —
Children's Hosp. of Boston NICHD CRS Boston Massachusetts 021155724 —
Baystate Health, Baystate Med. Ctr. Springfield Massachusetts 01199 —
Bronx-Lebanon Hosp. IMPAACT CRS The Bronx New York 10457 —
St. Christopher's Hosp. for Children Philadelphia Pennsylvania — —
St. Jude/UTHSC CRS Memphis Tennessee 381052794 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00038480, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2021 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00038480 live on ClinicalTrials.gov.

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