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Early ART for HIV (EARLIER Trial)
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.
EARLIER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEARLIER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EARLIER Trial Design
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Who is running the clinical trial?
Media Library
- I have discussed the safety of my ARV regimen during pregnancy with my doctor.I haven't used HIV prevention drugs in the 60 days before my acute HIV infection diagnosis.I am ready and willing to start antiretroviral therapy at enrollment.I am a woman capable of becoming pregnant.I regularly take medication that affects my immune system, like steroids.I am not able to have children, or my male partner is sterile.I am not pregnant and agree not to try to conceive while on the study treatment.My medical records show a diagnosis of acute HIV-1 within the last week.I was diagnosed with acute HIV infection within 60 days after trying a new HIV treatment or vaccine.
- Group 1: Arm 1: Fiebig I/II
- Group 2: Arm 2: Fiebig III/IV
- Group 3: Arm 3: Fiebig V
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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"
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."
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."
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"
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."
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."
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."
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