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Antiretroviral Therapy

Early ART for HIV (EARLIER Trial)

Phase 2
Waitlist Available
Research Sponsored by AIDS Clinical Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability and willingness to initiate ART at enrollment
Female candidates of reproductive potential who are not pregnant at the time of enrollment and who will receive the study-provided EVG/COBI/FTC/TAF and must agree not to participate in the conception process
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 48
Awards & highlights

EARLIER Trial Summary

This trial looked at whether starting antiretroviral therapy (ART) early, as soon as the infection is found, affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection.

Who is the study for?
This trial is for individuals recently diagnosed with acute HIV-1 infection who can start treatment immediately and are willing to follow the study plan for up to 72 weeks. Women of childbearing potential must use contraception, and participants should not have any health conditions that could affect their participation or be on immune-modifying drugs.Check my eligibility
What is being tested?
The trial tests early antiretroviral therapy (ART) using FDA-approved medications like elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide among others. It aims to see how early ART affects HIV-1 levels in blood, the body's response, and the amount of virus in CD4+ T-cells after 48 weeks.See study design
What are the potential side effects?
Potential side effects from ART may include nausea, headaches, fatigue, diarrhea, and possible allergic reactions. Long-term use might also impact liver function, bone density or cause other systemic issues.

EARLIER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am ready and willing to start antiretroviral therapy at enrollment.
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I am not pregnant and agree not to try to conceive while on the study treatment.

EARLIER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Secondary outcome measures
GAG Gene
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation

EARLIER Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3: Fiebig VExperimental Treatment1 Intervention
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
Group II: Arm 2: Fiebig III/IVExperimental Treatment1 Intervention
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
Group III: Arm 1: Fiebig I/IIExperimental Treatment1 Intervention
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).

Find a Location

Who is running the clinical trial?

AIDS Clinical Trials GroupLead Sponsor
100 Previous Clinical Trials
73,492 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,261 Previous Clinical Trials
5,482,811 Total Patients Enrolled

Media Library

bictegravir/emtricitabine/tenofovir alafenamide (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02859558 — Phase 2
HIV Research Study Groups: Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV, Arm 3: Fiebig V
HIV Clinical Trial 2023: bictegravir/emtricitabine/tenofovir alafenamide Highlights & Side Effects. Trial Name: NCT02859558 — Phase 2
bictegravir/emtricitabine/tenofovir alafenamide (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02859558 — Phase 2

Frequently Asked Questions

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

What goals is this experiment hoping to accomplish?

"The principal aim of this 48 week clinical trial is to analyse the proportion of participants with undetectable cell-associated HIV-1 DNA (CAHD). Other secondary objectives include evaluating HIV-1-specific CD4+ and CD8+ T-cell responses utilising flow cytometry, as well as measuring polyfunctional response frequency and type prior to ART initiation. Additionally, percentages pertaining to cytokine/marker expression in both HIV 1 specific CD4+ and CD8+ T cells will be measured against nef/tat/rev/vpr/vpu, gag, pol and env using background control value subtraction for"

Answered by AI

Are elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapies viable options for individuals?

"Although elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other FDA-approved antiretroviral therapy has only demonstrated safety in phase 2 trials, our team at Power believe it should receive a rating of 2."

Answered by AI

To what conditions are elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide, and other approved antiretroviral therapies frequently prescribed?

"Antiretroviral agents such as elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide are accepted treatments for HIV-1, treatment naive individuals without darunavir resistance. These medications may also be employed to address other medical conditions."

Answered by AI

How many volunteers are signing up for this research endeavor?

"This research endeavour has already completed its recruitment process. It was initially made public on January 1st, 2017 and the most recent edit occurred in January 24th 2022. If you are searching for another trial to participate in, 851 studies recruiting individuals with contagious illnesses and 103 trials looking for participants experienced with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide (or additional accepted FDA-approved antiretroviral therapy) are currently being conducted"

Answered by AI

What is the scope of this clinical trial's distribution?

"27 clinical sites are associated with this medical trial, including the University of Colorado Hospital CRS (6101) in Aurora, UCLA CARE Center CRS (601) in Los Angeles and Hosp. of the Univ. of Pennsylvania CRS (6201)in Philadelphia; an additional 24 locations are also included."

Answered by AI

Is there any empirical evidence of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide and other FDA-approved antiretroviral therapies yielding positive results?

"In 2002, the University of Zurich led a study on elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide as well as other FDA-approved antiretroviral treatments. This research has already yielded 387 completed studies and 103 active ones; notably many are running out of Aurora, Colorado."

Answered by AI

Is the recruitment period for this investigation still available?

"Clinicaltrials.gov data confirms that this specific trial, initially posted on January 1st 2017 and last updated on 24th of January 2022, is not recruiting patients right now. Nonetheless, there are still 954 other trials actively seeking participants at the present moment."

Answered by AI
~24 spots leftby Mar 2025