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Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children

NCT00312091 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-11-02

No results posted yet for this study

Summary

The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.

Conditions

  • HIV Infections

Interventions

DRUG

Lamivudine, nevirapine, and stavudine fixed-dose tablet

7 mg d4T, 30 mg 3TC, 50 mg NVP tablet

DRUG

Lamivudine

Dosage dependent on weight. More information on this criterion can be found in the protocol.

DRUG

Nevirapine

Dosage dependent on weight. More information on this criterion can be found in the protocol.

DRUG

Stavudine

Dosage dependent on weight. More information on this criterion can be found in the protocol.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Nirun Vanprapar, MD · Pediatric Infectious Unit, Department of Pediatrics, Siriraj Hopstial, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Thailand

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 NCT00312091 on ClinicalTrials.gov