Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV

June 23, 2005 updated by: Triangle Pharmaceuticals

An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients

The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Children are placed into 1 of 4 treatment groups based on age: Group 1, 3 months to 24 months; Group 2, 25 months to 6 years; Group 3, 7 years to 12 years; Group 4, 13 years to 17 years. They receive baseline evaluations. Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. Antiretroviral-experienced patients replace lamivudine with emtricitabine. Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48. Safety is evaluated using adverse events, which are reviewed at every clinic visit. Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. After the Week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Active, not recruiting
        • Fundacion HUES
  • Mexico
      • Col Roma, Mexico
        • Active, not recruiting
        • Instituto Mexicano de Investigación Clinica
  • Panama
      • Panama City, Panama
        • Active, not recruiting
        • Hospital del Nino
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • Active, not recruiting
        • Univ of Puerto Rico / Med Science Campus
  • South Africa
      • Diepkloof, South Africa
        • Recruiting
        • Perinatal HIV Research Unit
        • Contact:
      • Gaunteng, South Africa
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • USC School of Medicine / LA County Med Ctr
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Active, not recruiting
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, United States, 331016960
        • Active, not recruiting
        • Univ of Miami
    • New York
      • Bronx, New York, United States, 10461
        • Active, not recruiting
        • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
      • New York, New York, United States, 10021
        • Active, not recruiting
        • New York Hosp / Cornell Med Ctr
      • New York, New York, United States, 10025
        • Active, not recruiting
        • St Luke's - Roosevelt Hosp Ctr
      • Stony Brook, New York, United States, 117948111
        • Active, not recruiting
        • State Univ of New York at Stony Brook
    • Tennessee
      • Memphis, Tennessee, United States, 381052794
        • Active, not recruiting
        • Saint Jude Children's Research Hosp of Memphis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Children may be eligible for this study if they:

  • Are at least 3 months old and no older than 17 years of age. This is the age the child needs to be at the time they begin the study.
  • Are HIV positive.
  • Weigh more than 5.5 pounds. A newborn child must have reached at least 38 weeks of gestation.
  • Have or have not taken anti-HIV drugs. Those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. Those that have must have been taking anti-HIV drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening.
  • Have a CD4 count of more than 200 cells/mm3.
  • Have written consent from parent or guardian.
  • Are willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine, if sexually active.

Exclusion Criteria

Children will not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Cannot follow the visit or dosing schedule or are not available for 1 year.
  • Have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start.
  • Have nerve damage in their arms or legs.
  • Have trouble eating or taking drugs.
  • Have serious diarrhea within 30 days before study entry.
  • Have had any serious illness within 30 days of study screening. Any treatment must have been finished 14 days before study entry.
  • Have had an AIDS-related (opportunistic) disease within 12 months of screening.
  • Are being treated for tuberculosis.
  • Have had pancreatitis.
  • Require certain drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Triangle Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 23, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 298D
  • FTC-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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