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Antiretroviral

B/F/TAF for HIV

Q: What condition is B/F/TAF (Adult Strength) most often prescribed for?

B/F/TAF (Adult Strength) is most often used as an anti-retroviral agent. It can also be given to treat conditions such as treatment naive, no resistance to darunavir, human immunodeficiency virus type 1 (<a href="https://www.withpower.com/clinical-trials/hiv">hiv</a>-1).

Q: How many people are being recruited for this clinical trial?

Unfortunately, this particular study is no longer looking for new participants. Although, there are many other trials that might be of interest. For example, there are 110 clinical trials involving human immunodeficiency virus type 1 (<a href="https://www.withpower.com/clinical-trials/hiv">hiv</a>-1) infection and 105 B/F/TAF (Adult Strength) trials actively recruiting patients.

Q: Are researchers looking for more participants for this clinical trial?

This particular trial is no longer recruiting patients. The study was originally posted on September 21st, 2016 and the most recent edit was on September 10th, 2022. There are other options available; as of right now, there are 110 trials actively seeking participants who have human immunodeficiency virus type 1 (<a href="https://www.withpower.com/clinical-trials/hiv">hiv</a>-1) infection and 105 studies for B/F/TAF (Adult Strength).

Q: Is the B/F/TAF (Adult Strength) medication commonly studied in other medical research?

The original study for B/F/TAF (Adult Strength) took place in 2002 at University of Zurich. Out of the 355 completed trials, 105 are still active as of now. Many of these studies are based in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>.

Q: In how many different geographical areas is this trial taking place?

In addition to St. Christopher's Hospital for Children/Section of Immunology in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> and Children's National Health System in <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>, District of Columbia, this trial is also being conducted out of Duke Children's Health Center, Pediatric Infectious Diseases in Durham, <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a> amongst 10 other hospitals.

Q: Is this study only enrolling individuals who are twenty or older?

Children as young as one month old may participate in this clinical trial, so long as they are under the age of 18. Out of the 201 total trials, 32 are for patients younger than 18 and 169 are for people 65 years or older.

Q: How can I qualify to take part in this research?

This clinical trial is looking for 122 individuals that are <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-1 positive, ranging in age from 1 month to 17 years old. Patients must also meet the following criteria: Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to &#x3C; 25 kg) who are virologically suppressed for ≥ 6 months prior to screening., Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to &#x3C; 14 kg) who are treatment naive or on ARV treatment for ≥ 1 month prior to screening, Cohort 1: HIV

Phase 2 & 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I

Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, ≥ 14 days prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Awards & highlights

Study Summary

This trial is studying a 3-drug combination pill (bictegravir/emtricitabine/tenofovir alafenamide) to treat HIV in children and adolescents.

Who is the study for?

This trial is for children and adolescents with HIV-1 who have been virologically suppressed for at least 6 months. It includes different age groups: those aged 12 to <18 years weighing ≥35 kg, those aged 6 to <12 years weighing ≥25 kg, and younger children down to infants of ≥1 month old with varying weight requirements. Participants must have a stable antiretroviral regimen, good kidney function (eGFR ≥90 mL/min/1.73 m^2), and no resistance to certain HIV medications.Check my eligibility

What is being tested?

The study tests various doses of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in fixed dose combinations for safety and how the body processes them. The goal is also to confirm the appropriate dosing for these age groups while monitoring their response to this combination therapy.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal issues like nausea or diarrhea, headaches, fatigue, allergic reactions, and changes in liver or kidney function tests. Specific side effects will be monitored closely due to the young age of participants.

Eligibility Criteria

Inclusion Criteria

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

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My HIV does not resist common medications like FTC, TFV, or INSTIs.

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I last took nevirapine or efavirenz 14 days ago or more.

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I have been on the same HIV medication for at least a month or have not started treatment.

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My baby's kidney function is normal for their age.

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My HIV does not have resistance to certain HIV medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 or week 4 for cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; week 2 for cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; week 2 for cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PK Parameter: AUClast of TAF (Cohort 4)

PK Parameter: AUCtau of Bictegravir

PK Parameter: Cmax of TAF (Cohort 4)

+3 more

Secondary outcome measures

Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts)

Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4)

Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4)

+33 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Open-Label ExtensionExperimental Treatment3 Interventions

Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.

Group II: Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg)Experimental Treatment1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group III: Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg)Experimental Treatment1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group IV: Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg)Experimental Treatment1 Intervention

Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Group V: Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg)Experimental Treatment1 Intervention

Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2. Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48.

Group VI: Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg)Experimental Treatment1 Intervention

Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48. Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48.

Group VII: Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg)Experimental Treatment1 Intervention

Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48.

Group VIII: Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg)Experimental Treatment1 Intervention

Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48. Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,307 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,521 Total Patients Enrolled

Media Library

Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT02881320 — Phase 2 & 3

HIV Research Study Groups: Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg), Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg), Open-Label Extension, Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg), Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg), Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg), Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg), Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg)

HIV Clinical Trial 2023: Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination Highlights & Side Effects. Trial Name: NCT02881320 — Phase 2 & 3

Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02881320 — Phase 2 & 3

Frequently Asked Questions

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

What condition is B/F/TAF (Adult Strength) most often prescribed for?

"B/F/TAF (Adult Strength) is most often used as an anti-retroviral agent. It can also be given to treat conditions such as treatment naive, no resistance to darunavir, human immunodeficiency virus type 1 (hiv-1)."

Answered by AI

How many people are being recruited for this clinical trial?

"Unfortunately, this particular study is no longer looking for new participants. Although, there are many other trials that might be of interest. For example, there are 110 clinical trials involving human immunodeficiency virus type 1 (hiv-1) infection and 105 B/F/TAF (Adult Strength) trials actively recruiting patients."

Answered by AI

Are researchers looking for more participants for this clinical trial?

"This particular trial is no longer recruiting patients. The study was originally posted on September 21st, 2016 and the most recent edit was on September 10th, 2022. There are other options available; as of right now, there are 110 trials actively seeking participants who have human immunodeficiency virus type 1 (hiv-1) infection and 105 studies for B/F/TAF (Adult Strength)."

Answered by AI

Is the B/F/TAF (Adult Strength) medication commonly studied in other medical research?

"The original study for B/F/TAF (Adult Strength) took place in 2002 at University of Zurich. Out of the 355 completed trials, 105 are still active as of now. Many of these studies are based in Philadelphia, Pennsylvania."

Answered by AI

In how many different geographical areas is this trial taking place?

"In addition to St. Christopher's Hospital for Children/Section of Immunology in Philadelphia, Pennsylvania and Children's National Health System in Washington, District of Columbia, this trial is also being conducted out of Duke Children's Health Center, Pediatric Infectious Diseases in Durham, North carolina amongst 10 other hospitals."

Answered by AI

Is this study only enrolling individuals who are twenty or older?

"Children as young as one month old may participate in this clinical trial, so long as they are under the age of 18. Out of the 201 total trials, 32 are for patients younger than 18 and 169 are for people 65 years or older."

Answered by AI

How can I qualify to take part in this research?

"This clinical trial is looking for 122 individuals that are HIV-1 positive, ranging in age from 1 month to 17 years old. Patients must also meet the following criteria: Cohort 3: HIV-1 infected children (≥ 2 years of age and screening weight of ≥ 14 to < 25 kg) who are virologically suppressed for ≥ 6 months prior to screening., Cohort 4 Group 2-4: HIV-1 infected children (≥ 1 month of age and screening weight of ≥ 3 to < 14 kg) who are treatment naive or on ARV treatment for ≥ 1 month prior to screening, Cohort 1: HIV"

Answered by AI