A Phase IV, Prospective, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily PI & Once-Daily Non-NRTI – Containing Therapy Combinations for Initial Treatment of HIV-1 Infected individuals from Resource – Limited Settings (PEARLS) Trial

Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID)

Protocol Summary: A5175 was a phase IV, randomized, open-label, three-arm, antiviral efficacy trial designed to evaluate three antiretroviral (ARV) regimens for treatment-naïve HIV-infected participants: one regimen containing two nucleoside reverse transcriptase inhibitors (NRTIs) + a protease inhibitor (PI) and two regimens each containing two NRTIs + a non-nucleoside reverse transcriptase inhibitor (NNRTI).

Years: 2005 – 2009

Investigator: James Hakim, MBChB, FRCP

Location: Parirenyatwa CRS


Completed Study


Campbell TB, Smeaton LM, Kumarasamy N, Flanigan T, Klingman KL, et al. (2012) Efficacy and Safety of Three Antiretroviral Regimens for Initial Treatment of HIV-1: A Randomized Clinical Trial in Diverse Multinational Settings. PLoS Med 9(8): e1001290.

Safren SA, Biello KB, Smeaton L, et al. (2014) Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG 5175/PEARLS trial. PLoS One. 2014 Aug 25;9(8):e104178.

Touzard Romo F, Smeaton LM, Campbell TB, et al. (2014) Renal and metabolic toxicities following initiation of HIV-1 treatment regimen in a diverser, multinational setting: a focused safety analysis of ACTG PEARLS (A5175). HIV Clin Trials. 2014 Nov-Dec;15(6):246-60.

Kantor R, Smeaton L, Vardhanabhuti S, et al. (2015) Pretreatment HIV Drug Resistance and HIV-1 Subtype C Are Independently Associated with Virologic Failure: Results from the Multinational PEARLS A5175) Clinical Trial. Clin Ifec Dis. 2015 May 15;60(10):1541-9.

Singini I, Campbell TB, Smeaton LM, et al (2016) Predictors of late virologic failure after initial successful suppression of HIV replication on efavirenz-based antiretroviral therapy. HIV Clin Trials. 2016 Jul 29: 1-8.

Celum C, Hong T, Cent A, et al. (2017) HSV-2 acquisition among HIV-1 infected adults treated with tenofovir as part of combination antiretroviral therapy: Results from the ACTG A5175 PEARLS study. J Infect Dis. 2017 Jan 30.

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