Early versus standard antiretroviral therapy for HIV-infected adults in Haiti

Patrice Severe, Marc Antoine Jean Juste, Alex Ambroise, Ludger Eliacin, Claudel Marchand, Sandra Apollon, Alison Edwards, Heejung Bang, Janet Nicotera, Catherine Godfrey, Roy M. Gulick, Warren D. Johnson, Jean William Pape, Daniel W. Fitzgerald

Research output: Contribution to journalArticle

280 Citations (Scopus)

Abstract

BACKGROUND: For adults with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts that are greater than 200 and less than 350 per cubic millimeter and who live in areas with limited resources, the optimal time to initiate antiretroviral therapy remains uncertain. METHODS: We conducted a randomized, open-label trial of early initiation of antiretroviral therapy, as compared with the standard timing for initiation of therapy, among HIV-infected adults in Haiti who had a confirmed CD4+ T-cell count that was greater than 200 and less than 350 per cubic millimeter at baseline and no history of an acquired immunodeficiency syndrome (AIDS) illness. The primary study end point was survival. The early-treatment group began taking zidovudine, lamivudine, and efavirenz therapy within 2 weeks after enrollment. The standard-treatment group started the same regimen of antiretroviral therapy when their CD4+ T-cell count fell to 200 per cubic millimeter or less or when clinical AIDS developed. Participants in both groups underwent monthly follow-up assessments and received isoniazid and trimethoprim-sulfamethoxazole prophylaxis with nutritional support. RESULTS: Between 2005 and 2008, a total of 816 participants - 408 per group - were enrolled and were followed for a median of 21 months. The CD4+ T-cell count at enrollment was approximately 280 per cubic millimeter in both groups. There were 23 deaths in the standard-treatment group, as compared with 6 in the early-treatment group (hazard ratio with standard treatment, 4.0; 95% confidence interval [CI], 1.6 to 9.8; P = 0.001). There were 36 incident cases of tuberculosis in the standard-treatment group, as compared with 18 in the early-treatment group (hazard ratio, 2.0; 95% CI, 1.2 to 3.6; P = 0.01). CONCLUSIONS: Early initiation of antiretroviral therapy decreased the rates of death and incident tuberculosis. Access to antiretroviral therapy should be expanded to include all HIVinfected adults who have CD4+ T-cell counts of less than 350 per cubic millimeter, including those who live in areas with limited resources. (ClinicalTrials.gov number, NCT00120510.)

Original languageEnglish (US)
Pages (from-to)257-265
Number of pages9
JournalNew England Journal of Medicine
Volume363
Issue number3
DOIs
StatePublished - Jul 15 2010
Externally publishedYes

Fingerprint

Haiti
HIV
CD4 Lymphocyte Count
Therapeutics
T-Lymphocytes
efavirenz
Acquired Immunodeficiency Syndrome
Tuberculosis
Confidence Intervals
Lamivudine
Nutritional Support
Zidovudine
Isoniazid
Sulfamethoxazole Drug Combination Trimethoprim
Virus Diseases

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Severe, P., Juste, M. A. J., Ambroise, A., Eliacin, L., Marchand, C., Apollon, S., ... Fitzgerald, D. W. (2010). Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. New England Journal of Medicine, 363(3), 257-265. https://doi.org/10.1056/NEJMoa0910370

Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. / Severe, Patrice; Juste, Marc Antoine Jean; Ambroise, Alex; Eliacin, Ludger; Marchand, Claudel; Apollon, Sandra; Edwards, Alison; Bang, Heejung; Nicotera, Janet; Godfrey, Catherine; Gulick, Roy M.; Johnson, Warren D.; Pape, Jean William; Fitzgerald, Daniel W.

In: New England Journal of Medicine, Vol. 363, No. 3, 15.07.2010, p. 257-265.

Research output: Contribution to journalArticle

Severe, P, Juste, MAJ, Ambroise, A, Eliacin, L, Marchand, C, Apollon, S, Edwards, A, Bang, H, Nicotera, J, Godfrey, C, Gulick, RM, Johnson, WD, Pape, JW & Fitzgerald, DW 2010, 'Early versus standard antiretroviral therapy for HIV-infected adults in Haiti', New England Journal of Medicine, vol. 363, no. 3, pp. 257-265. https://doi.org/10.1056/NEJMoa0910370
Severe P, Juste MAJ, Ambroise A, Eliacin L, Marchand C, Apollon S et al. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. New England Journal of Medicine. 2010 Jul 15;363(3):257-265. https://doi.org/10.1056/NEJMoa0910370
Severe, Patrice ; Juste, Marc Antoine Jean ; Ambroise, Alex ; Eliacin, Ludger ; Marchand, Claudel ; Apollon, Sandra ; Edwards, Alison ; Bang, Heejung ; Nicotera, Janet ; Godfrey, Catherine ; Gulick, Roy M. ; Johnson, Warren D. ; Pape, Jean William ; Fitzgerald, Daniel W. / Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. In: New England Journal of Medicine. 2010 ; Vol. 363, No. 3. pp. 257-265.
@article{728f492bae34490fa53b4b28f3f4036e,
title = "Early versus standard antiretroviral therapy for HIV-infected adults in Haiti",
abstract = "BACKGROUND: For adults with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts that are greater than 200 and less than 350 per cubic millimeter and who live in areas with limited resources, the optimal time to initiate antiretroviral therapy remains uncertain. METHODS: We conducted a randomized, open-label trial of early initiation of antiretroviral therapy, as compared with the standard timing for initiation of therapy, among HIV-infected adults in Haiti who had a confirmed CD4+ T-cell count that was greater than 200 and less than 350 per cubic millimeter at baseline and no history of an acquired immunodeficiency syndrome (AIDS) illness. The primary study end point was survival. The early-treatment group began taking zidovudine, lamivudine, and efavirenz therapy within 2 weeks after enrollment. The standard-treatment group started the same regimen of antiretroviral therapy when their CD4+ T-cell count fell to 200 per cubic millimeter or less or when clinical AIDS developed. Participants in both groups underwent monthly follow-up assessments and received isoniazid and trimethoprim-sulfamethoxazole prophylaxis with nutritional support. RESULTS: Between 2005 and 2008, a total of 816 participants - 408 per group - were enrolled and were followed for a median of 21 months. The CD4+ T-cell count at enrollment was approximately 280 per cubic millimeter in both groups. There were 23 deaths in the standard-treatment group, as compared with 6 in the early-treatment group (hazard ratio with standard treatment, 4.0; 95{\%} confidence interval [CI], 1.6 to 9.8; P = 0.001). There were 36 incident cases of tuberculosis in the standard-treatment group, as compared with 18 in the early-treatment group (hazard ratio, 2.0; 95{\%} CI, 1.2 to 3.6; P = 0.01). CONCLUSIONS: Early initiation of antiretroviral therapy decreased the rates of death and incident tuberculosis. Access to antiretroviral therapy should be expanded to include all HIVinfected adults who have CD4+ T-cell counts of less than 350 per cubic millimeter, including those who live in areas with limited resources. (ClinicalTrials.gov number, NCT00120510.)",
author = "Patrice Severe and Juste, {Marc Antoine Jean} and Alex Ambroise and Ludger Eliacin and Claudel Marchand and Sandra Apollon and Alison Edwards and Heejung Bang and Janet Nicotera and Catherine Godfrey and Gulick, {Roy M.} and Johnson, {Warren D.} and Pape, {Jean William} and Fitzgerald, {Daniel W.}",
year = "2010",
month = "7",
day = "15",
doi = "10.1056/NEJMoa0910370",
language = "English (US)",
volume = "363",
pages = "257--265",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "3",

}

TY - JOUR

T1 - Early versus standard antiretroviral therapy for HIV-infected adults in Haiti

AU - Severe, Patrice

AU - Juste, Marc Antoine Jean

AU - Ambroise, Alex

AU - Eliacin, Ludger

AU - Marchand, Claudel

AU - Apollon, Sandra

AU - Edwards, Alison

AU - Bang, Heejung

AU - Nicotera, Janet

AU - Godfrey, Catherine

AU - Gulick, Roy M.

AU - Johnson, Warren D.

AU - Pape, Jean William

AU - Fitzgerald, Daniel W.

PY - 2010/7/15

Y1 - 2010/7/15

N2 - BACKGROUND: For adults with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts that are greater than 200 and less than 350 per cubic millimeter and who live in areas with limited resources, the optimal time to initiate antiretroviral therapy remains uncertain. METHODS: We conducted a randomized, open-label trial of early initiation of antiretroviral therapy, as compared with the standard timing for initiation of therapy, among HIV-infected adults in Haiti who had a confirmed CD4+ T-cell count that was greater than 200 and less than 350 per cubic millimeter at baseline and no history of an acquired immunodeficiency syndrome (AIDS) illness. The primary study end point was survival. The early-treatment group began taking zidovudine, lamivudine, and efavirenz therapy within 2 weeks after enrollment. The standard-treatment group started the same regimen of antiretroviral therapy when their CD4+ T-cell count fell to 200 per cubic millimeter or less or when clinical AIDS developed. Participants in both groups underwent monthly follow-up assessments and received isoniazid and trimethoprim-sulfamethoxazole prophylaxis with nutritional support. RESULTS: Between 2005 and 2008, a total of 816 participants - 408 per group - were enrolled and were followed for a median of 21 months. The CD4+ T-cell count at enrollment was approximately 280 per cubic millimeter in both groups. There were 23 deaths in the standard-treatment group, as compared with 6 in the early-treatment group (hazard ratio with standard treatment, 4.0; 95% confidence interval [CI], 1.6 to 9.8; P = 0.001). There were 36 incident cases of tuberculosis in the standard-treatment group, as compared with 18 in the early-treatment group (hazard ratio, 2.0; 95% CI, 1.2 to 3.6; P = 0.01). CONCLUSIONS: Early initiation of antiretroviral therapy decreased the rates of death and incident tuberculosis. Access to antiretroviral therapy should be expanded to include all HIVinfected adults who have CD4+ T-cell counts of less than 350 per cubic millimeter, including those who live in areas with limited resources. (ClinicalTrials.gov number, NCT00120510.)

AB - BACKGROUND: For adults with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts that are greater than 200 and less than 350 per cubic millimeter and who live in areas with limited resources, the optimal time to initiate antiretroviral therapy remains uncertain. METHODS: We conducted a randomized, open-label trial of early initiation of antiretroviral therapy, as compared with the standard timing for initiation of therapy, among HIV-infected adults in Haiti who had a confirmed CD4+ T-cell count that was greater than 200 and less than 350 per cubic millimeter at baseline and no history of an acquired immunodeficiency syndrome (AIDS) illness. The primary study end point was survival. The early-treatment group began taking zidovudine, lamivudine, and efavirenz therapy within 2 weeks after enrollment. The standard-treatment group started the same regimen of antiretroviral therapy when their CD4+ T-cell count fell to 200 per cubic millimeter or less or when clinical AIDS developed. Participants in both groups underwent monthly follow-up assessments and received isoniazid and trimethoprim-sulfamethoxazole prophylaxis with nutritional support. RESULTS: Between 2005 and 2008, a total of 816 participants - 408 per group - were enrolled and were followed for a median of 21 months. The CD4+ T-cell count at enrollment was approximately 280 per cubic millimeter in both groups. There were 23 deaths in the standard-treatment group, as compared with 6 in the early-treatment group (hazard ratio with standard treatment, 4.0; 95% confidence interval [CI], 1.6 to 9.8; P = 0.001). There were 36 incident cases of tuberculosis in the standard-treatment group, as compared with 18 in the early-treatment group (hazard ratio, 2.0; 95% CI, 1.2 to 3.6; P = 0.01). CONCLUSIONS: Early initiation of antiretroviral therapy decreased the rates of death and incident tuberculosis. Access to antiretroviral therapy should be expanded to include all HIVinfected adults who have CD4+ T-cell counts of less than 350 per cubic millimeter, including those who live in areas with limited resources. (ClinicalTrials.gov number, NCT00120510.)

UR - http://www.scopus.com/inward/record.url?scp=77954630522&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77954630522&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa0910370

DO - 10.1056/NEJMoa0910370

M3 - Article

VL - 363

SP - 257

EP - 265

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 3

ER -