Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in Haiti

Summary

Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.

Timeline

Start

2007-07

Primary completion

2009-09

Completion

2009-09

Outcome

Met primary endpoint

paper There were 23 deaths in the standard-treatment group, as compared with 6 in the early-treatment group PMID 20647201 ↗

paper hazard ratio with standard treatment, 4.0; 95% confidence interval [CI], 1.6 to 9.8; P=0.001. PMID 20647201 ↗

Publications

• Background Blankson JN. Primary HIV-1 infection: to treat or not to treat? AIDS Read. 2005 May;15(5):245-6, 249-51.
• Background Duncombe C, Kerr SJ, Ruxrungtham K, Dore GJ, Law MG, Emery S, Lange JM, Phanuphak P, Cooper DA. HIV disease progression in a patient cohort treated via a clinical research network in a resource limited setting. AIDS. 2005 Jan 28;19(2):169-78. doi: 10.1097/00002030-200501280-00009.
• Background Pape JW. Tuberculosis and HIV in the Caribbean: approaches to diagnosis, treatment, and prophylaxis. Top HIV Med. 2004 Dec-2005 Jan;12(5):144-9.
• Background Teck R, Ascurra O, Gomani P, Manzi M, Pasulani O, Kusamale J, Salaniponi FM, Humblet P, Nunn P, Scano F, Harries AD, Zachariah R. WHO clinical staging of HIV infection and disease, tuberculosis and eligibility for antiretroviral treatment: relationship to CD4 lymphocyte counts. Int J Tuberc Lung Dis. 2005 Mar;9(3):258-62.
• Background Thorner A, Rosenberg E. Early versus delayed antiretroviral therapy in patients with HIV infection : a review of the current guidelines from an immunological perspective. Drugs. 2003;63(13):1325-37. doi: 10.2165/00003495-200363130-00001.
• Joseph Y, Yao Z, Dua A, Severe P, Collins SE, Bang H, Antoine Jean-Juste M, Ocheretina O, Apollon A, McNairy ML, Dupnik K, Cremieux E, Byrne A, Pape JW, Koenig SP. Long-term mortality after tuberculosis treatment among persons living with HIV in Haiti. J Int AIDS Soc. 2021 Jul;24(7):e25721. doi: 10.1002/jia2.25721.
• Collins SE, Jean Juste MA, Koenig SP, Secours R, Ocheretina O, Bernard D, Riviere C, Calnan M, Dunning A, Hurtado Rua SM, Johnson WD Jr, Pape JW, Fitzgerald DW, Severe P. CD4 deficit and tuberculosis risk persist with delayed antiretroviral therapy: 5-year data from CIPRA HT-001. Int J Tuberc Lung Dis. 2015 Jan;19(1):50-7. doi: 10.5588/ijtld.14.0217.
• Haas DW, Severe P, Jean Juste MA, Pape JW, Fitzgerald DW. Functional CYP2B6 variants and virologic response to an efavirenz-containing regimen in Port-au-Prince, Haiti. J Antimicrob Chemother. 2014 Aug;69(8):2187-90. doi: 10.1093/jac/dku088. Epub 2014 Apr 2.
• Koenig SP, Bang H, Severe P, Jean Juste MA, Ambroise A, Edwards A, Hippolyte J, Fitzgerald DW, McGreevy J, Riviere C, Marcelin S, Secours R, Johnson WD, Pape JW, Schackman BR. Cost-effectiveness of early versus standard antiretroviral therapy in HIV-infected adults in Haiti. PLoS Med. 2011 Sep;8(9):e1001095. doi: 10.1371/journal.pmed.1001095. Epub 2011 Sep 20.
• Severe P, Juste MA, Ambroise A, Eliacin L, Marchand C, Apollon S, Edwards A, Bang H, Nicotera J, Godfrey C, Gulick RM, Johnson WD Jr, Pape JW, Fitzgerald DW. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med. 2010 Jul 15;363(3):257-65. doi: 10.1056/NEJMoa0910370.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efavirenz	Other / unclassified	600 mg	Oral
Subject	Lamivudine	Other / unclassified	150 mg	Oral
Subject	Zidovudine	Small molecule	300 mg	Oral

Indications