Document Detail


Short-course antiretroviral therapy in primary HIV infection.
MedLine Citation:
PMID:  23323897     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Short-course antiretroviral therapy (ART) in primary human immunodeficiency virus (HIV) infection may delay disease progression but has not been adequately evaluated.
METHODS: We randomly assigned adults with primary HIV infection to ART for 48 weeks, ART for 12 weeks, or no ART (standard of care), with treatment initiated within 6 months after seroconversion. The primary end point was a CD4+ count of less than 350 cells per cubic millimeter or long-term ART initiation.
RESULTS: A total of 366 participants (60% men) underwent randomization to 48-week ART (123 participants), 12-week ART (120), or standard care (123), with an average follow-up of 4.2 years. The primary end point was reached in 50% of the 48-week ART group, as compared with 61% in each of the 12-week ART and standard-care groups. The average hazard ratio was 0.63 (95% confidence interval [CI], 0.45 to 0.90; P=0.01) for 48-week ART as compared with standard care and was 0.93 (95% CI, 0.67 to 1.29; P=0.67) for 12-week ART as compared with standard care. The proportion of participants who had a CD4+ count of less than 350 cells per cubic millimeter was 28% in the 48-week ART group, 40% in the 12-week group, and 40% in the standard-care group. Corresponding values for long-term ART initiation were 22%, 21%, and 22%. The median time to the primary end point was 65 weeks (95% CI, 17 to 114) longer with 48-week ART than with standard care. Post hoc analysis identified a trend toward a greater interval between ART initiation and the primary end point the closer that ART was initiated to estimated seroconversion (P=0.09), and 48-week ART conferred a reduction in the HIV RNA level of 0.44 log(10) copies per milliliter (95% CI, 0.25 to 0.64) 36 weeks after the completion of short-course therapy. There were no significant between-group differences in the incidence of the acquired immunodeficiency syndrome, death, or serious adverse events.
CONCLUSIONS: A 48-week course of ART in patients with primary HIV infection delayed disease progression, although not significantly longer than the duration of the treatment. There was no evidence of adverse effects of ART interruption on the clinical outcome. (Funded by the Wellcome Trust; SPARTAC Controlled-Trials.com number, ISRCTN76742797, and EudraCT number, 2004-000446-20.).
Authors:
; Sarah Fidler; Kholoud Porter; Fiona Ewings; John Frater; Gita Ramjee; David Cooper; Helen Rees; Martin Fisher; Mauro Schechter; Pontiano Kaleebu; Giuseppe Tambussi; Sabine Kinloch; Jose M Miro; Anthony Kelleher; Myra McClure; Steve Kaye; Michelle Gabriel; Rodney Phillips; Jonathan Weber; Abdel Babiker
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  368     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-17     Completed Date:  2013-01-23     Revised Date:  2014-04-08    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  207-17     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN76742797
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Retroviral Agents / administration & dosage*,  adverse effects,  therapeutic use
CD4 Lymphocyte Count
Disease Progression
Drug Administration Schedule
Female
Follow-Up Studies
HIV / genetics,  isolation & purification
HIV Infections / drug therapy*,  immunology
Humans
Male
Middle Aged
RNA, Viral / blood
Young Adult
Grant Support
ID/Acronym/Agency:
069598/Z/02/Z//Wellcome Trust; G108/626//Medical Research Council
Chemical
Reg. No./Substance:
0/Anti-Retroviral Agents; 0/RNA, Viral
Investigator
Investigator/Affiliation:
A Breckenridge / ; P Clayden / ; C Conlon / ; F Conradie / ; J Kaldor / ; F Maggiolo / ; F Ssali / ; D A Cooper / ; P Kaleebu / ; G Ramjee / ; M Schechter / ; G Tambussi / ; J Weber / ; S Fidler / ; A Babiker / ; T Peto / ; A McLaren / ; V Beral / ; G Chene / ; J Hakim / ; A Babiker / ; K Porter / ; M Thomason / ; F Ewings / ; M Gabriel / ; D Johnson / ; K Thompson / ; A Cursley / ; K Donegan / ; E Fossey / ; P Kelleher / ; K Lee / ; B Murphy / ; D Nock / ; R Phillips / ; J Frater / ; L Ohm Laursen / ; N Robinson / ; P Goulder / ; H Brown / ; M McClure / ; D Bonsall / ; O Erlwein / ; A Helander / ; S Kaye / ; M Robinson / ; L Cook / ; G Adcock / ; P Ahmed / ; N Paton / ; S Fidler / ; A Kelleher / ; R Moore / ; R McFarlane / ; N Roth / ; R Finlayson / ; B Kiem Tee / ; T Read / ; M Kelly / ; N Doong / ; M Bloch / ; C Workman / ; P Grey / ; D A Cooper / ; A Kelleher / ; M Law / ; M Schechter / ; P Gama / ; M Mercon / ; M Barbosa de Souza / ; C Beppu Yoshida / ; J R Grangeiro da Silva / ; A Sampaio Amaral / ; D Fernandes de Aguiar / ; M de Fátima Melo / ; R Quaresma Garrido / ; G Tambussi / ; S Nozza / ; M Pogliaghi / ; S Chiappetta / ; L Della Torre / ; E Gasparotto / ; G D'Offizi / ; C Vlassi / ; A Corpolongo / ; R Wood / ; J Pitt / ; C Orrell / ; F Cilliers / ; R Croxford / ; K Middelkoop / ; L G Bekker / ; C Heiberg / ; J Aploon / ; N Killa / ; E Fielder / ; T Buhler / ; H Rees / ; F Venter / ; T Palanee / ; W Stevens / ; C Ingram / ; M Majam / ; M Papathanasopoulos / ; G Ramjee / ; S Gappoo / ; J Moodley / ; A Premrajh / ; L Zako / ; H Grosskurth / ; A Kamali / ; P Kaleebu / ; U Bahemuka / ; J Mugisha / ; H F Njaj / ; J M Miro / ; M López-Dieguez / ; C Manzardo / ; J A Arnaiz / ; T Pumarola / ; M Plana / ; M Tuset / ; M C Ligero / ; M T García / ; T Gallart / ; J M Gatell / ; M Fisher / ; K Hobbs / ; N Perry / ; D Pao / ; D Maitland / ; L Heald / ; F Mulcahy / ; G Courtney / ; S O'Dea / ; D Reidy / ; C Leen / ; G Scott / ; L Ellis / ; S Morris / ; P Simmonds / ; B Gazzard / ; D Hawkins / ; C Higgs / ; J Anderson / ; S Mguni / ; I Williams / ; N De Esteban / ; P Pellegrino / ; A Arenas-Pinto / ; D Cornforth / ; J Turner / ; J Ainsworth / ; A Waters / ; M Johnson / ; S Kinloch / ; A Carroll / ; P Byrne / ; Z Cuthbertson / ; C Orkin / ; J Hand / ; C De Souza / ; J Weber / ; S Fidler / ; E Hamlyn / ; E Thomson / ; J Fox / ; K Legg / ; S Mullaney / ; A Winston / ; S Wilson / ; P Ambrose / ; S Taylor / ; G Gilleran / ; S Keeling / ; A Becker / ; C Boocock /
Comments/Corrections
Comment In:
N Engl J Med. 2013 May 23;368(21):2036-7   [PMID:  23697518 ]
J Comp Eff Res. 2013 May;2(3):227-9   [PMID:  24236621 ]
N Engl J Med. 2013 May 23;368(21):2036   [PMID:  23697519 ]
N Engl J Med. 2013 Jan 17;368(3):279-81   [PMID:  23323905 ]

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