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F/TAF for HIV-Controlled Pediatric Patients
Study Summary
This trial is studying the safety and effectiveness of a new HIV drug in children and adolescents who are already taking other HIV drugs and have had their HIV infection controlled for at least six months.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't taken part in a drug trial other than for tenofovir in the last 30 days.My body weight fits the trial's specific group requirements.I do not have any serious health or mental conditions that would affect my treatment.I haven't needed IV antibiotics or antifungals for a serious infection in the last 30 days.I have not had tuberculosis in the last 3 months.I am under 18 and HIV-1 positive.I have been on a stable HIV medication regimen for at least 6 months.I haven't had any serious infections in the last 30 days.I was diagnosed with an AIDS-indicator condition less than 30 days ago.I have an active hepatitis C infection.
- Group 1: F/TAF+3rd ARV agent (Cohort 1)
- Group 2: F/TAF+3rd ARV agent (Cohort 2, Group 1, Part A)
- Group 3: F/TAF+3rd ARV agent (Cohort 2, Group 2, Part A)
- Group 4: FTC/TAF+3rd ARV agent (Cohort 3, Part A)
- Group 5: FTC/TAF+3rd ARV agent (Cohort 4, Part A)
- Group 6: F/TAF+3rd ARV agent (Cohort 2, Group 1, Part B)
- Group 7: F/TAF+3rd ARV agent (Cohort 2, Group 2, Part B)
- Group 8: FTC/TAF+3rd ARV agent (Cohort 3, Part B)
- Group 9: FTC/TAF+3rd ARV agent (Cohort 4, Part B)
- Group 10: FTC/TAF +3rd ARV agent (Extension Phase)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this study have an age limit? If so, what is the cut-off age?
"The age bracket that this trial is recruiting from is 1 month old to 17 years old."
Are there any available positions for people who want to participate in this trial?
"According to the clinicaltrials.gov website, this clinical trial is not currently recruiting patients. The trial was first posted on 1/20/2015, and the most recent update was on 4/26/2022. Although this trial is not looking for patients right now, there are 9 other studies that are."
Are there restrictions on who is able to be a part of this research project?
"This study is looking for 41 HIV-1 positive participants between the ages of 1 month and 17 years old. Patients must meet the following criteria: Cohort 4: to be updated per a protocol amendment, Currently on a stable 2-NRTI containing regimen that includes a 3rd ARV agent for ≥ 6 consecutive months prior to screening, HIV-1 infected male and female adolescents and children aged 1 month to < 18 years at baseline/Day 1 (according to requirements of the enrolling cohort), Must be able to give written assent prior to any screening evaluations, Cohort 2, Group 2: 17 kg to <"
Which medical centers offer this particular clinical trial?
"Children's Hospital Colorado in Aurora, Colorado, St. Christopher's Hospital for Children in Philadelphia, Pennsylvania, Seattle Children's Hospital in Seattle, Washington, and 4 other sites are conducting this trial."
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