B/F/TAF (Adult Strength) for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Phase-Based Estimates
1
Effectiveness
2
Safety
Be Part Ypluntu Centre, Cape Town, South Africa
B/F/TAF (Adult Strength) - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Study Summary

This study is evaluating the safety and tolerability of a new drug combination in children.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether B/F/TAF (Adult Strength) will improve 6 primary outcomes and 36 secondary outcomes in patients with Human Immunodeficiency Virus Type 1 (HIV-1) Infection. Measurement will happen over the course of Week 1.

Day 1
Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts)
Palatability of B/F/TAF Formulation at Day 1 (All Cohorts)
Up to 24 weeks
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
Up to 48 weeks
Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through Week 48
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48
Week 1
Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4)
Palatability of B/F/TAF Formulation at Week 1 (Cohort 4)
Week 2
Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4)
Palatability of B/F/TAF Formulation at Week 2 (Cohort 4)
Week 2
PK Parameter: AUClast of FTC (Cohorts 4)
PK Parameter: AUClast of TAF (Cohort 4)
PK Parameter: Cmax of FTC (Cohorts 4)
PK Parameter: Cmax of TAF (Cohort 4)
Week 4
PK Parameter: AUClast of TAF and FTC (Cohorts 1, 2, and 3)
PK Parameter: Cmax of TAF and FTC (Cohorts 1, 2, and 3)
Week 4
PK Parameter: AUClast of Bictegravir
PK Parameter: AUCtau of Bictegravir
PK Parameter: AUCtau of TAF and FTC
PK Parameter: Apparent CL of TAF and FTC
PK Parameter: Apparent Clearance (CL) of Bictegravir
PK Parameter: Apparent Vz of Bictegravir
PK Parameter: Apparent Vz of TAF and FTC
PK Parameter: Cmax of Bictegravir
PK Parameter: Ctau of Bictegravir
PK Parameter: Ctau of TAF and FTC
PK Parameter: T1/2 of Bictegravir
PK Parameter: T1/2 of TAF and FTC
PK Parameter: Tmax of Bictegravir
PK Parameter: Tmax of TAF and FTC
Week 24
Acceptability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Change from Baseline in CD4+ Cell Count Percentages at Week 24
Change from Baseline in CD4+ Cell Counts at Week 24
Palatability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
Week 4
Acceptability of B/F/TAF Formulation at Week 4 (All Cohorts)
Palatability of B/F/TAF Formulation at Week 4 (All Cohorts)
Week 48
Acceptability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Change from Baseline in CD4+ Cell Count Percentages at Week 48
Change from Baseline in CD4+ Cell Counts at Week 48
Palatability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

8 Treatment Groups

No Control Group
Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg)

This trial requires 122 total participants across 8 different treatment groups

This trial involves 8 different treatments. B/F/TAF (Adult Strength) is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Cohort 4 Group 4 (≥ 1 month of age and weight ≥ 3 to < 6 kg)
Drug
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS through Week 48.
Cohort 4 Group 1 (≥ 2 years of age and weight ≥ 14 to < 25 kg)
Drug
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) through Week 48.
Cohort 2 (6 to < 12 years of age and weight ≥ 25 kg)
Drug
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.
Open-Label ExtensionFollowing 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.
Cohort 1 (12 to < 18 years of age and weight ≥ 35 kg)
Drug
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.
Cohort 4 Group 3 (≥ 1 month of age and weight ≥ 6 to < 10 kg)
Drug
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS through Week 48.
Cohort 3 (≥ 2 years of age and weight ≥ 14 to < 25 kg)
Drug
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.
Cohort 4 Group 2 (≥ 1 month of age and weight ≥ 10 to < 14 kg)
Drug
Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS through Week 48.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.

Closest Location

Wayne State University - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. You must have received newly diagnosed for Human Immunodeficiency Virus Type 1 (HIV-1) Infection. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This group of children have been infected with HIV-1, and have been free of the virus for at least six months. show original
Cohort 3 consists of HIV-1 infected children who have been virologically suppressed for at least six months prior to screening and have a screening weight of at least 14 kg but less than 25 kg. show original
Children aged 2 years or older who have a screening weight of 14 to 25 kilograms and who have been virologically suppressed for at least 6 months prior to screening will be in Cohort 4 Group 1 show original
Individuals must be on a stable antiretroviral regimen for at least 6 months before they can be screened for a clinical study show original
HIV-1 RNA levels must be below 50 copies/mL on a stable regimen for at least 6 months before screening in order to be considered "undetectable." An HIV-1 RNA level of 50 or more copies/mL (a "blip") in the weeks or months before screening is acceptable show original
A group of HIV-1 infected adolescents who have been virologically suppressed for six months or more prior to screening are cohort 1. show original
The estimated glomerular filtration rate (GFR) is ≥90 mL/min/1.73 m^2 according to the Schwartz Formula. show original
There are no known resistances 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. show original
and have a screening weight of ≥ 3 to < 14 kg This group includes HIV-1 infected children who are treatment naive or on ARV treatment for at least one month prior to screening and have a screening weight of at least 3 to less than 14 kg. show original
If you are younger than 18 months old, you will need a confirmatory nucleic acid-based test if you receive a positive HIV test result. show original

Patient Q&A Section

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

What are the signs of human immunodeficiency virus type 1 (hiv-1) infection?

Add answer

A person experiencing symptoms of AIDS has the following disease stages: (1) stage of infection with HIV; (2) AIDS symptoms; (3) immune system dysfunction; and (4) severe immune system dysfunction.

Unverified Answer

What causes human immunodeficiency virus type 1 (hiv-1) infection?

Add answer

HIV-1 infection is acquired at different ages by different routes. The age at sexual debut has an effect on the risk of acquiring the virus. The age of acquiring HIV-1 infection influences the risk of presenting with AIDS.

Unverified Answer

How many people get human immunodeficiency virus type 1 (hiv-1) infection a year in the United States?

Add answer

HIV-1 seroprevalence is increasing in the US. In 2010, the virus was detectable in 2.4 million US citizens and 2.5 million resident non-citizens. More than 1 million US citizens were infected with HIV. These trends do not seem to be related to incidence.

Unverified Answer

Can human immunodeficiency virus type 1 (hiv-1) infection be cured?

Add answer

The available data suggest that an effective vaccine cannot be developed as yet. However, recent developments suggest that it will be possible in the near future. HIV-1 virus and its components (nucleic acid) play a critical role throughout the entire life cycle for its transmission. Understanding the structure and dynamics of the virus and its components (nucleic acids) has been fundamental to this development of vaccine and its practical applications to control the virus in the body and to eradicate HIV-1 from humans and other primates in animal experiments. Currently, the goal of developing a curative vaccine in humans is not achievable.

Unverified Answer

What are common treatments for human immunodeficiency virus type 1 (hiv-1) infection?

Add answer

Treatment regimes for HIV-1 infection vary and can be complex depending on the nature of the infection, the number, or severity of previous infections, and the patient's tolerance to therapies. Clinicians have used a range of antiretroviral drugs to treat HIV-1-associated diseases. Current therapies may provide effective long-term management although most have significant toxicities, such as the development of osteoporosis, a risk factor for fracture when HIV-1-associated osteopenia is present.

Unverified Answer

What is human immunodeficiency virus type 1 (hiv-1) infection?

Add answer

HIV-1 infection is a pandemic infectious disease that is one of the main causes of pediatric mortality within the world. HIV-1 infection is primarily transmitted through sexual and vertical transmission. Transmission of HIV-1 occurs through contact with blood and body fluids and through the transmission via breast feeding. Human infections are typically characterized by the acquisition of HIV-1 by contact with an HIV-1-infected person. HIV-1 infection can be confirmed biochemically and serologically with the aid of HIV-1 ELISA assay methodologies and Western blotting methodologies and by polymerase chain reaction (PCR) assays for viral genomic material.

Unverified Answer

What is the latest research for human immunodeficiency virus type 1 (hiv-1) infection?

Add answer

It is important for physicians and patients to keep up to date with current research as information is constantly evolving. The studies cited in the following sections offer insights into new insights into HIV.\n- Researchers have conducted an open-label study that has been ongoing since November 2008 to determine whether the drug efalizumab, when administered with a protease inhibitor drug, decreases the risk of developing an infection in patients with HIV-1 who have not been treated with antiretroviral therapy. The study began in late 2008 and concluded in late 2010.

Unverified Answer

Have there been any new discoveries for treating human immunodeficiency virus type 1 (hiv-1) infection?

Add answer

There are no newly discovered treatments for HIV-1 infection, but therapies continue to improve dramatically due to advances in AIDS research and treatment. There are still many unanswered questions left in HIV-1 biology and treatment response that need to be investigated. Although there are more discoveries annually than ever before, there will still be many unanswered questions the future and progress in AIDS research will offer.

Unverified Answer

Who should consider clinical trials for human immunodeficiency virus type 1 (hiv-1) infection?

Add answer

Clinical trials for hiv-1 infection are underrepresented among African-American/African-American females with a lifetime risk of HIV infection ≥20% (defined as >80% if tested) who may be eligible to participate. [Age, HIV testing] have a marked inverse relationship to enrollment in clinical trials. Therefore, targeted outreach campaigns (through health personnel and other members of the LGBT community) in high incidence areas may be essential to increase enrollment in clinical trials for hiv-1 infection.

Unverified Answer

What are the latest developments in b/f/taf (adult strength) for therapeutic use?

Add answer

There is still work to be done prior to BFTAS gaining full governmental support, but the research is currently leading the way. While the progress is evident on the development of BFTAS, the major challenge is to create an effective and safer sublingual formulation of BFTAS.

Unverified Answer

Is b/f/taf (adult strength) safe for people?

Add answer

Exposure of healthy blood donors to HIV/AIDS-associated viruses or to B,F, and T is safe. No significant risk of exposure was observed in donation profiles associated with increased HIV exposure. Results from a recent paper challenge the consensus that B-linked traits are inherently higher risk.

Unverified Answer

How does b/f/taf (adult strength) work?

Add answer

b/f/taf is a versatile tool for the study of RNA polymerase regulation by small RNAs in plant leaves. It enables the identification of tmts with differing roles in b/f-directed RNA polymerase maturation, which opens the way to dissect their function. Overall, this study suggests that a novel mode of action by plant tmts, i.e., alteration of RNA polymerase activity, may provide benefits in terms of plant fitness.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Human Immunodeficiency Virus Type 1 (HIV-1) Infection by sharing your contact details with the study coordinator.