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Adefovir + Nelfinavir for HIV

Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child is 3 months to 16 years old
Child has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test a new anti-HIV drug in children who are already taking other medications. It will assess if the new drug is safe and effective.

Who is the study for?
This trial is for HIV-infected children aged 3 months to 16 years who are already on anti-HIV drugs and have not changed their regimen in the last two weeks. They must not have used certain protease inhibitors or be willing to stop them if they have, agree to use barrier contraception methods, and have parental consent.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of adding Adefovir Dipivoxil (a new anti-HIV drug) and Nelfinavir to existing anti-HIV therapies in these children. It aims to determine how well this combination works as part of their treatment plan.See study design
What are the potential side effects?
Potential side effects may include digestive issues, changes in liver function, allergic reactions, headaches, weakness or fatigue. As with all medications, individual experiences with side effects can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 3 months and 16 years old.
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My child has not used or is willing to stop using certain HIV medications for the study.

Timeline

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

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,805 Total Patients Enrolled

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT00002219 — Phase 2
Human Immunodeficiency Virus Infection Research Study Groups:
Human Immunodeficiency Virus Infection Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT00002219 — Phase 2
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT00002219 — Phase 2

Frequently Asked Questions

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

What is the prevalence of this medical experiment within U.S. healthcare facilities?

"Currently, this clinical trial is available in 7 different medical facilities located across New york, Charleston and Durham. To reduce the burden of travel for potential participants, it would be beneficial to select the closest clinic to you prior to enrollment."

Answered by AI

Does the FDA certify this treatment?

"Despite lacking evidence for efficacy, the safety of this treatment has been partially validated and hence garnered a rating of 2."

Answered by AI

Is there an age cap on participants in this research endeavor?

"The sample size for this study demands that participants are between three months and sixteen years of age. Specifically, 108 people under the legal adult age must be enrolled while 353 elderly individuals require recruitment."

Answered by AI

What are the criteria for joining this medical experiment?

"This clinical trial is enlisting 36 minors aged 3 months to 16 years, who are HIV positive and taking an anti-HIV drug regimen that will remain unaltered for two weeks prior. Additionally, any participants must adhere to a number of criteria like refraining from protease inhibitors unless they have previously taken ritonavir (RTV), saquinavir (SQV) or indinavir (IDV). Furthermore, the responsible parent/guardian must agree for them to use barrier methods of contraception during their involvement in the study."

Answered by AI
~24 spots leftby Apr 2025