Early time-limited antiretroviral therapy versus deferred therapy in South African infants infected with HIV: Results from the children with HIV early antiretroviral (CHER) randomised trial

The Lancet

Volumn 382, Issue 9904, 2013, Pages 1555-1563

  Cotton, Mark F ^a   Violari, Avy ^b   Otwombe, Kennedy ^b   Panchia, Ravindre ^b   Dobbels, Els ^a   Rabie, Helena ^a   Josipovic, Deirdre ^b   Liberty, Afaaf ^b   Lazarus, Erica ^b   Innes, Steve ^a   Van Rensburg, Anita Janse ^a   Pelser, Wilma ^b   Truter, Handre ^b   Madhi, Shabir A ^b   Handelsman, Edward ^c   Jean Philippe, Patrick ^d   McIntyre, James A ^e   Gibb, Diana M ^f   Babiker, Abdel G ^f  

^a UNIVERSITY OF STELLENBOSCH   (South Africa)

^b UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^c NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^d HENRY M JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE   (United States)

^e UNIVERSITY OF CAPE TOWN   (South Africa)

^f MEDICAL RESEARCH COUNCIL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ANTIRETROVIRUS AGENT; DIDANOSINE; EFAVIRENZ; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; VIRUS RNA; ZIDOVUDINE;

ACUTE KIDNEY FAILURE; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CD4+ T LYMPHOCYTE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DISEASE COURSE; FOLLOW UP; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROENTERITIS; HAZARD RATIO; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFANT; LIPOATROPHY; MAJOR CLINICAL STUDY; MYOCARDITIS; NEUTROPENIA; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOUTH AFRICA; THROMBOCYTOPENIA; VERTICAL TRANSMISSION; VIRUS LOAD;

EID: 84887243970     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(13)61409-9     Document Type: Article

References (32)

1. Bourne DE, Thompson M, Brody LL, et al. Emergence of a peak in early infant mortality due to HIV/AIDS in South Africa. AIDS 2009; 23: 101-06.
2. Violari A, Cotton MF, Gibb DM, et al, for the CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med 2008; 359: 2233-44.
3. Marinda E, Humphrey JH, Iliff PJ, et al, and the ZVITAMBO Study Group. Child mortality according to maternal and infant HIV status in Zimbabwe. Pediatr Infect Dis J 2007; 26: 519-26.
4. Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F, and the Ghent International AIDS Society (IAS) Working Group on HIV Infection in Women and Children. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet 2004; 364: 1236-43.
5. Church JD, Omer SB, Guay LA, et al. Analysis of nevirapine (NVP) resistance in Ugandan infants who were HIV infected despite receiving single-dose (SD) NVP versus SD NVP plus daily NVP up to 6 weeks of age to prevent HIV vertical transmission. J Infect Dis 2008; 198: 1075-82.
6. Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Washington, DC: US Department of Health and Human Services, 2007.
7. Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the use of antiretroviral agents in pediatric HIV infection. Washington, DC: US Department of Health and Human Services, 2008.
8. Welch S, Sharland M, Lyall EG, et al, and the PENTA Steering Committee. PENTA 2009 guidelines for the use of antiretroviral therapy in paediatric HIV-1 infection. HIV Med 2009; 10: 591-613.
9. WHO. Antiretroviral therapy of HIV infection in infants and children in resource-limited settings: towards universal access. Recommendations for a public health approach. Geneva: World Health Organization, 2006.
10. Chadwick EG, Caparelli EV, Yogev R, et al. Pharmacokinetics, safety and efficacy of lopinavir/ritonavir in infants less than 6 months of age: 24 week results AIDS 2008; 22: 249-55.
11. National Department of Health. National Antiretroviral Treatment Guidelines. In: Department of Health, ed. 1st edn. Pinetown: Jacana Publishers, 2004.
12. Division of AIDS, National Institute of Allergy and Infectious Diseases. Table for grading the severity of adult and pediatric adverse events, 1994. http://rsc.tech-res.com/Document/safetyandpharmacovigilance/Table-for-Grading- Severity-of-Adult-Pediatric-Adverse-Events.pdf (accessed Jan 4, 2012).
13. Madhi S, Adrian P, Cotton MF, et al. Effect of HIV infection status and antiretroviral treatment on quantitative and qualitative antibody responses to pneumococcal conjugate vaccine in infants. J Infect Dis 2010; 202: 335-61.
14. Centers For Disease Control and Prevention. Revised classification system for human immunodeficiency virus infection in children less than 13 years of age. MMWR Morb Mortal Wkly Rep 1994; 43: 1-10.
15. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976; 34: 585-612.
16. Persaud D, Gay H, Ziemniak C, et al. Functional HIV cure after very early ART of an infected infant. 20th Conference on Retroviruses and Opportunistic Infections; Atlanta, GA, USA; March 3-6, 2013. Abstract 48LB.
17. Sáez-Cirión A, Bacchus C, Hocqueloux L, et al, and the ANRS VISCONTI Study Group. Post-treatment HIV-1 controllers with a long-term virological remission after the interruption of early initiated antiretroviral therapy ANRS VISCONTI Study. PLoS Pathog 2013; 9: e1003211.
18. Meyer-Rath G, Violari A, Cotton MF, et al. The cost of early vs deferred paediatric antiretroviral treatment in South Africa - a comparative economic analysis of the first year of the CHER trial. XVIII International AIDS Congress; Vienna, Austria; 18-23 July, 2010. Abstract THLBB103.
19. Prendergast A, Mphatswe W, Tudor-Williams G, et al. Early virological suppression with three-class antiretroviral therapy in HIV-infected African infants. AIDS 2008; 22: 1333-43.
20. Wamalwa D, Benki-Nugent S, Langat A, et al. Treatment interruption in infants following 24 months of empiric ART: Kenya. 19th Conference on Retrovirology and Opportunistic Infection; Seattle, WA, USA; March 5-8, 2012. Abstract 27.
21. Kinloch-De Loës S, Hirschel BJ, Hoen B, et al. A controlled trial of zidovudine in primary human immunodeficiency virus infection. N Engl J Med 1995; 333: 408-13.
22. Grijsen ML, Steingrover R, Wit FW, et al, and the Primo-SHM Study Group. No treatment versus 24 or 60 weeks of antiretroviral treatment during primary HIV infection: the randomized Primo-SHM trial. PLoS Med 2012; 9: e1001196.
23. Hogan CM, Degruttola V, Sun X, et al, and the A5217 Study Team. The setpoint study (ACTG A5217): effect of immediate versus deferred antiretroviral therapy on virologic set point in recently HIV-1-infected individuals. J Infect Dis 2012; 205: 87-96.
24. Fidler S, Porter K, Ewings F, et al, and the SPARTAC Trial Investigators. Short-course antiretroviral therapy in primary HIV infection. N Engl J Med 2013; 368: 207-17.
25. El-Sadr WM, Lundgren J, Neaton JD, et al, and the Strategies for Management of Antiretroviral Therapy (SMART) Study Group. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med 2006; 355: 2283-96.
26. Paediatric European Network for Treatment of AIDS. Response to planned treatment interruptions in HIV infection varies across childhood. AIDS 2010; 24: 231-41.
27. Laughton B, Cornell M, Grove D, et al. Early antiretroviral therapy improves neurodevelopmental outcomes in infants. AIDS 2012; 26: 1685-90.
28. Ramos J, Melvin D, Medin G, et al. Neurocognitive and quality of life outcomes in children after planned treatment interruptions: the randomized PENTA 11 trial. 19th Conference on Retrovirology and Opportunistic Infection; Seattle, WA, USA; March 5-8, 2012. Poster 963.
29. Puthanakit T, Ananworanich J, Vonthanak S, et al. Cognitive function and neurodevelopmental outcomes in HIV-infected childrenolder than 1 year of age randomized to early versus deferred antiretroviral therapy: the PREDICT neurodevelopmental study. Pediatr Infect Dis J 2013; 32: 501-08.
30. PENPACT-1 (PENTA 9/PACTG 390) Study Team, Babiker A, Castronee Green H, et al. First-line antiretroviral therapy with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor and switch at higher versus low viral load in HIV-infected children: an open-label, randomised phase 2/3 trial. Lancet Infect Dis 2011; 11: 273-83.
31. Violari A, Lindsey JC, Hughes MD, et al. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. N Engl J Med 2012; 366: 2380-89.
32. UNAIDS. UNAIDS report on the global AIDS epidemic, 2012. Geneva: UNAIDS, 2012.