Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT02859558
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2016-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Early ART to Limit Infection and Establishment of Reservoir
Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Organization:
Study Overview
Official Title:
Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARLIER
Brief Summary:
The study was done to:
* Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1
* See how starting ART 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
* Look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells (infection-fighting cells in blood) after 48 weeks of ART
* See how early treatment for HIV affects the numbers of HIV-1 infection fighting cells (CD4+ and CD8+ T-cells) in blood
* Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1
* See how starting ART 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
* Look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells (infection-fighting cells in blood) after 48 weeks of ART
* See how early treatment for HIV affects the numbers of HIV-1 infection fighting cells (CD4+ and CD8+ T-cells) in blood
Detailed Description:
This was a Phase II, prospective, open-label two-step study to measure the effects of early ART on the establishment of HIV-1 reservoir and HIV-1-specific immunity. Participants were enrolled if they fulfilled the inclusion criteria for acute HIV-1 infection (AHI) diagnosis within 7 days prior to entry and had an enrollment visit with the immediate initiation of ART. Plasma and serum samples for Fiebig staging were collected at the time of ART initiation.
Participants were followed for up to 216 weeks (72 weeks on Step 1 and 144 weeks on Step 2). Evaluations at weeks 2 and 8 on Step 1 were performed via telephone.
The Fiebig stage-classification system was used to characterize the progression from HIV-1 exposure to HIV-1 seroconversion at the time of ART initiation. In this study, the five Fiebig stages of interest were simplified into three study groups as described below (based on HIV-1 antibody diagnostic profile at time of ART initiation).
The primary analysis was based on Step 1. Step 2 was added to the study for long term follow-up. The rationale for the extended follow-up period was to expand the number of available participants for future therapeutic and cure studies without the burden of frequent visits and the cost of study-provided laboratory testing.
Group 1: Fiebig I/II (non-reactive HIV-1 antibody)
Group 2: Fiebig III/IV (reactive HIV-1 antibody and negative or indeterminate results on the Western Blot (WB) or Geenius HIV-1/HIV-2)
Group 3: Fiebig V (reactive HIV-1 antibody and positive WB or Geenius HIV-1/HIV-2 without p31 band)
Although participants in Fiebig VI (positive WB or Geenius HIV-1/HIV-2 with p31 band) were not specifically targeted for enrollment in this study, it was possible that a small number of participants would be determined to be in Fiebig VI (positive Western blot or Geenius HIV-1/HIV-2 with p31 band) based on analysis of the entry samples. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1, allowing ample time for them to pursue alternative sources for ART. Enrolled participants without HIV or in Fiebig VI were replaced.
The study-provided regimen was single tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Other non-study-provided antiretroviral (ARV) regimens were also allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Participants were followed for up to 216 weeks (72 weeks on Step 1 and 144 weeks on Step 2). Evaluations at weeks 2 and 8 on Step 1 were performed via telephone.
The Fiebig stage-classification system was used to characterize the progression from HIV-1 exposure to HIV-1 seroconversion at the time of ART initiation. In this study, the five Fiebig stages of interest were simplified into three study groups as described below (based on HIV-1 antibody diagnostic profile at time of ART initiation).
The primary analysis was based on Step 1. Step 2 was added to the study for long term follow-up. The rationale for the extended follow-up period was to expand the number of available participants for future therapeutic and cure studies without the burden of frequent visits and the cost of study-provided laboratory testing.
Group 1: Fiebig I/II (non-reactive HIV-1 antibody)
Group 2: Fiebig III/IV (reactive HIV-1 antibody and negative or indeterminate results on the Western Blot (WB) or Geenius HIV-1/HIV-2)
Group 3: Fiebig V (reactive HIV-1 antibody and positive WB or Geenius HIV-1/HIV-2 without p31 band)
Although participants in Fiebig VI (positive WB or Geenius HIV-1/HIV-2 with p31 band) were not specifically targeted for enrollment in this study, it was possible that a small number of participants would be determined to be in Fiebig VI (positive Western blot or Geenius HIV-1/HIV-2 with p31 band) based on analysis of the entry samples. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1, allowing ample time for them to pursue alternative sources for ART. Enrolled participants without HIV or in Fiebig VI were replaced.
The study-provided regimen was single tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Other non-study-provided antiretroviral (ARV) regimens were also allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2UM1AI068636 | NIH | None | https://reporter.nih.gov/quic… | View |