Early ART to Limit Infection and Establishment of Reservoir

Phase 2 Completed 195 enrolled Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2017-01-24
Primary completion: 2020-12-02
Completion: 2025-04-16

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm 1: Fiebig I/II vs Arm 2: Fiebig III/IV; p = 0.48; Fisher Exact; NCT02859558 ↗

Publications

Crowell TA, Ritz J, Coombs RW, Zheng L, Eron JJ, Mellors JW, Dragavon J, van Zyl GU, Lama JR, Ruxrungtham K, Grinsztejn B, Arduino RC, Fox L, Ananworanich J, Daar ES; AIDS Clinical Trials Group A5354/EARLIER (Early ART to Limit Infection and Establishment of Reservoir) Study Team. Novel Criteria for Diagnosing Acute and Early Human Immunodeficiency Virus Infection in a Multinational Study of Early Antiretroviral Therapy Initiation. Clin Infect Dis. 2021 Aug 2;73(3):e643-e651. doi: 10.1093/cid/ciaa1893.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bictegravir/emtricitabine/tenofovir alafenamide	Unknown	—	Oral
Subject	elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide	Unknown	—	Oral