Studies

Paediatric randomized to early versus deferred initiation in Cambodia and Thailand (PREDICT)

December 31, 2014

Project no.: HIV-NAT 035

This is an open label, randomized phase III study comparing early versus deferred (starting HAART when CD4+ falls below 15%) initiation of HAART in anti-retroviral-naive children aged one to 12 years with CDC paediatric clinical classification category A or B and CD4+ between 15 to 24%. (NCT 00234091)

Publications:

  1. Lessons from a multicentre paediatric HIV trial.  Lancet. 2008 Aug 2;372(9636):356-7.
  2. CD4 Cell Count Criteria to Determine When to Initiate Antiretroviral Therapy in Human Immunodeficiency Virus-Infected Children. Pediatr Infect Dis J.Oct 2010;29(10):966-8.
  3. Ananworanich J,Apornpong T, Kosalaraksa P, Jaimulwong T, Hansudewechakul R, Pancharoen C, Bunupuradah T,Chandara M, Puthanakit T, Ngampiyasakul C, Wongsawat J, Kanjanavanit S, Luesomboon W, Klangsinsirikul P, Ngo-Giang-Huong N, Kerr SJ, Ubolyam S, Mengthaisong T, Gelman RS, Pattanapanyasat K, Saphonn V, Ruxrungtham K, Shearer WT;PREDICT Study Group. Characteristics of lymphocyte subsets in HIV-infected, long-term nonprogressor, and healthy Asian children through 12years of age. J Allergy Clin Immunol. 2010 Dec;126(6):1294-301.
  4. High prevalence of lipid abnormalities among Antiretroviral-naive HIV-infected Asian children with mild to moderate immunosuppression. Antiviral Therapy. 2011;16(8):1351-5.
  5. Poor quality of life among untreated Thai and Cambodian children without severe HIV symptoms. AIDS care. 2012;24(1):30-8.
  6. Puthanakit T, Saphonn V, Ananworanich J, Kosalaraksa P, Hansudewechakul R, Vibol U, Kerr SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Ngo-Giang-Huong N, Chettra K, Cheunyam T, Suwarnlerk T, Ubolyam S, Shearer WT, Paul R, Mofenson LM, Fox L, Law MG, Cooper DA, Phanuphak P, Vun MC, Ruxrungtham K; on behalf of the PREDICT Study Group. Early versus deferred antiretroviral therapy for children older than 1 year infected with HIV (PREDICT): a multicentre, randomised, open-label trial. Lancet Infect Dis. 2012 Oct 8. pii: S1473-3099(12)70242-6.
  7. Puthanakit T, Bunupuradah T, Kosalaraksa P, Vibol U, Hansudewechakul R, Ubolyam S, Suwanlerk T, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Ananworanich J, Ruxrungtham K. Prevalence of HLA-B*5701among HIV-Infected Children in Thailand and Cambodia: Implications for Abacavir Use. Pediatr Infect Dis J. 2012 Sep 17.
  8. Bunupuradah T, Ubolyam S, Hansudewechakul R, Kosalaraksa P, Ngampiyaskul C, Kanjanavanit S, Wongsawat J, Luesomboon W, Pinyakorn S, Kerr S, Ananworanich J, Chomtho S, van der Lugt J, Luplertlop N, Ruxrungtham K,Puthanakit T; PREDICT study group. Correlation of selenium and zinc levels to antiretroviral treatment outcomes in Thai HIV-infected children without severe HIV symptoms. Eur J Clin Nutr. 2012 Aug;66(8):900-5.
  9. Kanjanavanit S,Puthanakit T, Vibol U, Kosalaraksa P, Hansudewechakul R, Ngampiyasakul C, Wongsawat J, Luesomboon W, Wongsabut J, Mahanontharit A, Suwanlerk T, Saphonn V, Ananworanich J, Ruxrungtham K; PREDICT study group. High prevalence of lipid abnormalities among antiretroviral-naive HIV-infected Asian children with mild-to-moderate immunosuppression. Antivir Ther. 2011;16(8):1351-5.
  10. Prevalence of anemia and underlying iron status in naïve antiretroviral therapy HIV-infected children with moderate immune suppression. AIDS Research and Human Retroviruses 2012 Dec;28(12):1679-86.
  11. Impact of Antiretroviral Therapy on Quality of Life in HIV-Infected Southeast Asian Children in the PREDICT Study. AIDS Patient Care and STDs 2013 Nov; 27(11):596-603.
  12. AIDS Patient Care and STDs 2014;28(6):296-302.

Presentations:

  1. Five-year experience in Thailand of using CLIA and ISO to establish a laboratory network for US NIAID Pediatric Clinical Trials. [CD Rom Abstract #CDD278] presented at the 6th IAS. July 17-20, 2011. Rome, Italy.
  2. Improved in iron status and anemia in HIV-infected children after zidovudine-containing HAART without routine iron supplementation. [poster # MOPE255]presented at the 6th IAS. July 17-20, 2011. Rome, Italy.
  3. Incidence and risk factors for nevirapine related toxicities among HIV-infected Asian children randomized to starting ART at different CD4%. [Poster # MOPE240] presented at the 6th IAS. July 17-20, 2011. Rome, Italy.
  4. Randomized clinical trial of immediate versus deferred antiretroviral therapy initiation in children older than one year with moderate immunodeficiency: The PREDICT Study (NCT00234091). [Poster # LBPE023; abstract # TULBPE023] presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. 17-20 July 2011. Rome, Italy.
  5. Impact of Selenium and Zinc level on antiretroviral treatment outcomes in Thai HIV infected children. [Poster # P_29]* presented at 3rd International Workshop on HIV Pediatrics. 15 – 16 July 2011, Rome, Italy and 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. 17-20 July 2011. Rome, Italy. There are substudies for PREDICT
  6. Incidence of asthma in HIV-infected children after starting antiretroviral therapy. (Poster # P_56) Presented at the 5th International Workshop on HIV Pediatrics, June 28-29, 2013, Kuala Lumpur, Malaysia.
  7. Comparison of adherence monitoring tools and correlation to virologic failure in a pediatric HIV clinical trial. Presented at the 5th International Workshop on HIV Pediatrics (Poster # P_52). Also presented at the 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention (Poster # WEPE525).