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Nucleoside Reverse Transcriptase Inhibitor

Emtricitabine for HIV in Children

Phase 2

Waitlist Available

Research Sponsored by Triangle Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged 3 months to 17 years who are HIV positive

Children weighing more than 5.5 pounds or newborns who have reached at least 38 weeks of gestation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test the safety of emtricitabine in HIV-infected children, and find the best dose for them.

Who is the study for?

This trial is for HIV-positive children aged 3 months to 17 years, weighing over 5.5 pounds, with specific viral load criteria depending on prior anti-HIV drug use. They must have a CD4 count above 200 cells/mm3 and consent from a parent or guardian. Sexually active participants must commit to effective birth control during the study.Check my eligibility

What is being tested?

The study aims to assess the safety of emtricitabine in HIV-infected children and establish the optimal dosage when taken daily alongside other anti-HIV medications.See study design

What are the potential side effects?

Potential side effects may include digestive issues, allergic reactions, changes in blood counts or liver enzymes, and possibly long-term resistance to medication if not taken as prescribed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 months and 17 years old and HIV positive.

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My child weighs over 5.5 pounds or was born at 38 weeks or later.

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My child has HIV and meets the specific viral load criteria.

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My child's CD4 count is above 200.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Triangle PharmaceuticalsLead Sponsor

11 Previous Clinical Trials

859 Total Patients Enrolled

Media Library

Emtricitabine (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00017992 — Phase 2

Human Immunodeficiency Virus Infection Research Study Groups:

Human Immunodeficiency Virus Infection Clinical Trial 2023: Emtricitabine Highlights & Side Effects. Trial Name: NCT00017992 — Phase 2

Emtricitabine (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00017992 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this test only consider participants who are 35 years or younger?

"The age restriction for this clinical trial is 3 months to 17 years old."

Answered by AI

Who meets the inclusion criteria for this research project?

"This study is recruiting 100 people who are between 3 months and 17 years old and have HIV infections. The following criteria must also be met: being at least 3 months old but no older than 17 years of age (this is the age the child needs to be at the time they begin the study), weighing more than 5.5 pounds, having written consent from parent or guardian, being willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine if sexually active, being HIV positive."

Answered by AI

Has this particular medication been federally sanctioned?

"This is a Phase 2 trial, which means that while there is some evidence supporting the safety of this treatment, there is no data to support its efficacy. Our team at Power has rated the safety as a 2."

Answered by AI