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Antiretroviral

E/C/F/TAF for HIV-1 Infection

Q: Are there other ongoing investigations which concern E/C/F/TAF?

E/C/F/TAF is being trialed in 25 phase 3 studies, 110 of which are still active. These trials are occurring <a href="https://www.withpower.com/clinical-trials/all">all</a> over the world with 1680 different clinical trial sites, though many are concentrated in Boylston, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>.

Q: What are the most common illnesses that E/C/F/TAF has been shown to be effective for?

E/C/F/TAF is frequently used to manage human immunodeficiency virus type 1 (<a href="https://www.withpower.com/clinical-trials/hiv">hiv</a>-1). However, it also has potential applications in the treatment of hiv infections, hiv transmission, and human immunodeficiency virus type 1 (hiv-1) infection.

Q: Are there a lot of hospitals participating in this research project in North America?

Currently, there are 5 sites enrolling patients for this trial. These locations include St. Jude Children's Research Hospital in Memphis, Children's Research Institute in <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>, Miller's Children Hospital in Long Beach, and 2 other undisclosed centres.

Q: Does this research only pertain to elderly patients?

For this specific study, only children aged 2 to 17 are eligible. In general, there are 176 clinical trials for drugs involving patients under 18 and 481 studies for elderly patients.

Q: Are researchers actively recruiting people for this experiment?

Unfortunately, this trial is no longer recruiting patients as of the most recent update on clinicaltrials.gov from June 10th, 2022. The study was first posted on May 6th, 2013. Although this specific study might be closed to new participants, there are many other ongoing studies that are still looking for volunteers.

Phase 2 & 3

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

Cohort 3: Age at baseline: ≥ 2 years old, Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs), Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at week 4

Awards & highlights

Study Summary

This trial is studying a four-drug combination pill to treat HIV-1 in adolescents and children. The objectives are to evaluate the safety and tolerability of the pill and to study how it is processed by the body.

Who is the study for?

This trial is for HIV-1 infected adolescents who haven't had anti-HIV drugs (12-<18 years, over 35kg) and children both new to treatment (6-<12 years, over 25kg) and those already on a stable regimen without resistance to the study drug components. Excluded are those with hepatitis B/C, recent tuberculosis, or pregnant/lactating females.Check my eligibility

What is being tested?

The trial tests E/C/F/TAF single tablet regimens at standard and low doses in different age groups. It aims to understand how the body processes the medication (pharmacokinetics), confirm dosing for effectiveness, and assess safety over a period of up to 24 weeks.See study design

What are the potential side effects?

Potential side effects may include digestive issues like nausea or diarrhea, headaches, fatigue, skin reactions such as rash or itching. Long-term risks could involve bone density changes or kidney function alterations.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 2 years old, weigh between 31 and 55 lbs, have had undetectable HIV levels for 6 months, and no resistance to my current HIV treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose at week 4 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Therapeutic procedure

Cohort 2: Percentage of Participants With All Treatment-Emergent AEs and Treatment-Emergent SAEs

Therapeutic procedure

+6 more

Secondary outcome measures

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 24

Cohort 1: Change From Baseline in CD4+ Cell Count at Week 48

Cohort 1: Change From Baseline in CD4+ Cell Percentage at Week 24

+54 more

Side effects data

From 2016 Phase 3 trial • 79 Patients • NCT02071082

23%

Upper respiratory tract infection

12%

Nasopharyngitis

11%

Diarrhoea

Gastrooesophageal reflux disease

Back pain

Bronchitis

Rhinitis allergic

Sinusitis

Cough

Pyrexia

Benign prostatic hyperplasia

Chlamydial infection

Gonorrhoea

Influenza

Skin papilloma

Syphilis

Vomiting

Pneumonia pneumococcal

Prostatitis

Appendicitis

Renal cell carcinoma

Small intestinal obstruction

Meningitis pneumococcal

Rib fracture

Gastritis

Abscess limb

Cerebrovascular accident

Diabetes mellitus

Calculus urethral

Acute myocardial infarction

Chest pain

Pneumococcal bacteraemia

Pneumonia

Herpes zoster

Injury

100%

80%

60%

40%

20%

Study treatment Arm

HIV-Suppressed

HIV/HBV Treatment-Naive

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kgExperimental Treatment2 Interventions

Virologically suppressed HIV-infected children (≥ 2 years of age weighing ≥ 14 to < 25 kg) will receive E/C/F/TAF (90/90/120/6 mg) FDC once daily for 48 weeks. Participants who attain a weight of ≥ 25 kg during the course of the study will switch to adult E/C/F/TAF (150/150/200/10 mg) tablets. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF became commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Group II: Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kgExperimental Treatment1 Intervention

Virologically suppressed HIV-infected children (6 to < 12 years of age weighing ≥ 25 kg) will receive E/C/F/TAF (150/150/200/10 mg) FDC once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Group III: Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kgExperimental Treatment1 Intervention

HIV-infected, ARV treatment-naive adolescents (12 to < 18 years of age weighing ≥ 35 kg) will receive E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E/C/F/TAF in an extension phase of the study until: a) the participant turns 18 years old and E/C/F/TAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E/C/F/TAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E/C/F/TAF in that country.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

E/C/F/TAF

2016

Completed Phase 3

~5870

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

842,712 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,706 Total Patients Enrolled

Media Library

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT01854775 — Phase 2 & 3

Human Immunodeficiency Virus Infection Research Study Groups: Cohort 1: Age 12 to < 18 Years and Weight ≥ 35 kg, Cohort 2: Age 6 to < 12 Years and Weight ≥ 25 kg, Cohort 3: Age ≥2 Years and Weight ≥ 14 to <25 kg

Human Immunodeficiency Virus Infection Clinical Trial 2023: Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Highlights & Side Effects. Trial Name: NCT01854775 — Phase 2 & 3

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01854775 — Phase 2 & 3

Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT01854775 — Phase 2 & 3

Frequently Asked Questions

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

Are there other ongoing investigations which concern E/C/F/TAF?

"E/C/F/TAF is being trialed in 25 phase 3 studies, 110 of which are still active. These trials are occurring all over the world with 1680 different clinical trial sites, though many are concentrated in Boylston, Massachusetts."

Answered by AI

What are the most common illnesses that E/C/F/TAF has been shown to be effective for?

"E/C/F/TAF is frequently used to manage human immunodeficiency virus type 1 (hiv-1). However, it also has potential applications in the treatment of hiv infections, hiv transmission, and human immunodeficiency virus type 1 (hiv-1) infection."

Answered by AI

Are there a lot of hospitals participating in this research project in North America?

"Currently, there are 5 sites enrolling patients for this trial. These locations include St. Jude Children's Research Hospital in Memphis, Children's Research Institute in Washington, Miller's Children Hospital in Long Beach, and 2 other undisclosed centres."

Answered by AI

Does this research only pertain to elderly patients?

"For this specific study, only children aged 2 to 17 are eligible. In general, there are 176 clinical trials for drugs involving patients under 18 and 481 studies for elderly patients."

Answered by AI

Are researchers actively recruiting people for this experiment?

"Unfortunately, this trial is no longer recruiting patients as of the most recent update on clinicaltrials.gov from June 10th, 2022. The study was first posted on May 6th, 2013. Although this specific study might be closed to new participants, there are many other ongoing studies that are still looking for volunteers."

Answered by AI