What side effects are associated with this type of intervention?

Common treatments for HIV, such as the E/C/F/TAF STR regimen, have several known side effects. Elvitegravir is generally well tolerated but can cause mild gastrointestinal issues and headaches. Cobicistat can inhibit renal tubular secretion of creatinine, leading to increased serum creatinine levels and reduced estimated glomerular filtration rate. Emtricitabine is usually well tolerated but may cause hyperpigmentation of the skin. Tenofovir Alafenamide is preferred over its predecessor, Tenofovir Disoproxil Fumarate, due to its lower risk of renal and bone toxicity, though it can still cause mild gastrointestinal symptoms and potential renal issues. Overall, these treatments are effective and have manageable side effects.

What prior FDA approvals exist?

The FDA has approved several drugs and combinations for the treatment of HIV infection that are similar to the E/C/F/TAF STR regimen. Elvitegravir, an integrase inhibitor, is often combined with cobicistat, a pharmacokinetic enhancer, to boost its effectiveness. Emtricitabine and tenofovir alafenamide are both NRTIs that have been widely used in various fixed-dose combinations. For instance, the combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (TDF) was previously approved under the brand name Stribild®. These combinations aim to simplify treatment regimens and improve adherence by reducing pill burden.

What other types of research exist?

Promising alternatives to E/C/F/TAF STR for HIV treatment in 2024 include: 1) Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), which combines a potent integrase inhibitor with NRTIs and has shown high efficacy and tolerability. 2) Dolutegravir/Lamivudine (DTG/3TC), a two-drug regimen that simplifies treatment while maintaining effectiveness. 3) Cabotegravir/Rilpivirine (CAB/RPV), a long-acting injectable regimen that offers the convenience of less frequent dosing. These alternatives provide effective viral suppression with different mechanisms and dosing schedules.

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Antiretroviral

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

Q: What is the mechanism of action of this treatment?

The E/C/F/TAF STR regimen for HIV treatment includes Elvitegravir, an integrase inhibitor that blocks the integration of viral DNA into the host genome; Cobicistat, a pharmacokinetic enhancer that increases the effectiveness of Elvitegravir; and Emtricitabine and Tenofovir Alafenamide, both NRTIs that inhibit reverse transcriptase, preventing viral replication. These mechanisms are crucial for reducing viral load, improving immune function, and minimizing HIV-related complications in patients.

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

Must not have

Individuals experiencing decompensated cirrhosis

Hepatitis B or hepatitis C virus infection

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

No Placebo-Only Group

Summary

This trial tests a single pill combining four HIV medications in adolescents and children. It aims to find the right dose and ensure safety for those new to treatment and those already on it. The pill works by stopping the virus from growing and spreading.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My liver is severely damaged and not functioning properly.

Select...

I have an infection with hepatitis B or C.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

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

Therapeutic procedure

+6 more

Secondary study objectives

Plasma Exchange

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, Based on Missing = Failure Analyses

Cohort 1: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24, as Defined by the FDA Snapshot Analysis

+40 more

Side effects data

From 2016 Phase 3 trial • 79 Patients • NCT02071082

33%

Nasopharyngitis

33%

Herpes zoster

33%

Vomiting

33%

Syphilis

33%

Upper respiratory tract infection

33%

Dental caries

33%

Diarrhoea

100%

80%

60%

40%

20%

Study treatment Arm

HIV/HBV Treatment-Naive

HIV-Suppressed

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The E/C/F/TAF STR regimen for HIV treatment includes Elvitegravir, an integrase inhibitor that blocks the integration of viral DNA into the host genome; Cobicistat, a pharmacokinetic enhancer that increases the effectiveness of Elvitegravir; and Emtricitabine and Tenofovir Alafenamide, both NRTIs that inhibit reverse transcriptase, preventing viral replication. These mechanisms are crucial for reducing viral load, improving immune function, and minimizing HIV-related complications in patients.

Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial.Cobicistat: a Novel Pharmacoenhancer for Co-Formulation with HIV Protease and Integrase Inhibitors.