When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)
NCT ID: NCT00234091
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2006-04-30
2011-09-30
Brief Summary
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Detailed Description
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This study will last 144 weeks. All participants will have a CD4 percentage (CD4%) between 15% and 24% and will be randomly assigned to either receive immediate or delayed HAART. The HAART regimen will consist of two nucleoside reverse transcriptase inhibitors, zidovudine and lamivudine. In addition, participants will also receive either one non-nucleoside reverse transcriptase inhibitor, nevirapine or efavirenz, or one protease inhibitor, ritonavir-boosted lopinavir or nelfinavir. Abacavir will replace zidovudine or lamivudine if participants experience toxicity to the regimen. Participants in the immediate treatment arm will receive HAART on Day 1 of the study regardless of their CD4%. Participants in the delayed treatment arm will receive HAART if their CD4% falls below 15 or if they develop a CDC Category C illness.
Study visits will occur every 4 weeks for the first 12 weeks and then every 12 weeks until the end of the study. Blood collection, physical exams, and medical and medication history reviews will occur at all visits. Adherence, quality of life, and lipodystrophy assessments will occur every 12 weeks for participants on HAART. Participants will be encouraged to enroll in a related substudy to examine the neurodevelopment of HIV infected children.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Immediate treatment; individuals receive HAART on Day 1 of the study
Abacavir
8 mg/kg (up to 300 mg/dose) take orally twice daily
Efavirenz
200 to 600 mg taken orally once daily
Lamivudine
4 mg/kg (up to 150 mg/dose) taken orally twice daily
Lopinavir/Ritonavir
230 mg/57.5 mg/m\^2 body surface area taken orally twice daily with food
Nelfinavir
45-55 mg/kg taken orally twice daily with food
Nevirapine
120 mg/m\^2 once daily for first 14 days, tehn 200 mg/m\^2 (up to 400 mg/day) twice daily
Zidovudine
180-240 mg/m\^2 every 12 hours (up to 300 mg/dose)
2
Delayed treatment; individuals receive HAART if their CD4 percentage falls below 15 percentage OR if they develop a CDC category C illness
Abacavir
8 mg/kg (up to 300 mg/dose) take orally twice daily
Efavirenz
200 to 600 mg taken orally once daily
Lamivudine
4 mg/kg (up to 150 mg/dose) taken orally twice daily
Lopinavir/Ritonavir
230 mg/57.5 mg/m\^2 body surface area taken orally twice daily with food
Nelfinavir
45-55 mg/kg taken orally twice daily with food
Nevirapine
120 mg/m\^2 once daily for first 14 days, tehn 200 mg/m\^2 (up to 400 mg/day) twice daily
Zidovudine
180-240 mg/m\^2 every 12 hours (up to 300 mg/dose)
Interventions
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Abacavir
8 mg/kg (up to 300 mg/dose) take orally twice daily
Efavirenz
200 to 600 mg taken orally once daily
Lamivudine
4 mg/kg (up to 150 mg/dose) taken orally twice daily
Lopinavir/Ritonavir
230 mg/57.5 mg/m\^2 body surface area taken orally twice daily with food
Nelfinavir
45-55 mg/kg taken orally twice daily with food
Nevirapine
120 mg/m\^2 once daily for first 14 days, tehn 200 mg/m\^2 (up to 400 mg/day) twice daily
Zidovudine
180-240 mg/m\^2 every 12 hours (up to 300 mg/dose)
Eligibility Criteria
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Inclusion Criteria
* Antiretroviral naive, defined as never receiving anti-HIV medications, receiving them for less than 7 days, or only receiving them to prevent mother-to-child transmission (MTCT)
* CD4% between 15 and 24 within 30 days prior to study entry
* CDC pediatric clinical classification A or B
* Parent or guardian willing to provide informed consent and willing to follow all study procedures and requirements
Exclusion Criteria
* Active AIDS-defining illnesses (CDC Category C) within 30 days prior to study entry
* Certain abnormal laboratory values
* Known kidney disease
* Known allergy or sensitivity to study drugs
* Require certain medications
* Pregnancy
1 Year
12 Years
ALL
No
Sponsors
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Comprehensive International Program of Research on AIDS
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Kiat Ruxrungtham, MD, MPH
Role: STUDY_CHAIR
Department of Medicine at Chulalongkorn University, Bangkok, Thailand
Saphonn Vonthanak, MD, PhD
Role: STUDY_CHAIR
National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia
Locations
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National Pediatric Hosp., Cambodia CIPRA CRS
Phnom Penh, , Cambodia
Social Health Clinic, Cambodia CIPRA CRS
Phnom Penh, , Cambodia
Hiv-Nat Cipra Crs
Pathumwan, Bangkok, Thailand
Chiang Rai Regional Hosp. CIPRA CRS
Muang, Changwat Chiang Rai, Thailand
Prapokklao Hosp. CIPRA CRS
Chanthaburi, , Thailand
Nakornping Hosp. CIPRA CRS
Chiang Mai, , Thailand
Queen Savang Vadhana Memorial Hosp. CIPRA CRS
Chon Buri, , Thailand
Srinagarind Hosp. CIPRA CRS
Khon Kaen, , Thailand
Bamrasnaradura Institute CIPRA CRS
Nonthaburi, , Thailand
Countries
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References
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Lindsey JC, Malee KM, Brouwers P, Hughes MD; PACTG 219C Study Team. Neurodevelopmental functioning in HIV-infected infants and young children before and after the introduction of protease inhibitor-based highly active antiretroviral therapy. Pediatrics. 2007 Mar;119(3):e681-93. doi: 10.1542/peds.2006-1145. Epub 2007 Feb 12.
Nikolic-Djokic D, Essajee S, Rigaud M, Kaul A, Chandwani S, Hoover W, Lawrence R, Pollack H, Sitnitskaya Y, Hagmann S, Jean-Philippe P, Chen SH, Radding J, Krasinski K, Borkowsky W. Immunoreconstitution in children receiving highly active antiretroviral therapy depends on the CD4 cell percentage at baseline. J Infect Dis. 2002 Feb 1;185(3):290-8. doi: 10.1086/338567. Epub 2002 Jan 8.
Puthanakit T, Aurpibul L, Oberdorfer P, Akarathum N, Kanjananit S, Wannarit P, Sirisanthana T, Sirisanthana V. Hospitalization and mortality among HIV-infected children after receiving highly active antiretroviral therapy. Clin Infect Dis. 2007 Feb 15;44(4):599-604. doi: 10.1086/510489. Epub 2007 Jan 9.
Walker AS, Doerholt K, Sharland M, Gibb DM; Collaborative HIV Paediatric Study (CHIPS) Steering Committee. Response to highly active antiretroviral therapy varies with age: the UK and Ireland Collaborative HIV Paediatric Study. AIDS. 2004 Sep 24;18(14):1915-24. doi: 10.1097/00002030-200409240-00007.
Paul RH, Cho KS, Belden AC, Mellins CA, Malee KM, Robbins RN, Salminen LE, Kerr SJ, Adhikari B, Garcia-Egan PM, Sophonphan J, Aurpibul L, Thongpibul K, Kosalaraksa P, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Vonthanak S, Suwanlerk T, Valcour VG, Preston-Campbell RN, Bolzenious JD, Robb ML, Ananworanich J, Puthanakit T; PREDICT Study Group. Machine-learning classification of neurocognitive performance in children with perinatal HIV initiating de novo antiretroviral therapy. AIDS. 2020 Apr 1;34(5):737-748. doi: 10.1097/QAD.0000000000002471.
Paul R, Apornpong T, Prasitsuebsai W, Puthanakit T, Saphonn V, Aurpibul L, Kosalaraksa P, Kanjanavanit S, Luesomboon W, Ngampiyaskul C, Suwanlerk T, Chettra K, Shearer WT, Valcour V, Ananworanich J, Kerr S. Cognition, Emotional Health, and Immunological Markers in Children With Long-Term Nonprogressive HIV. J Acquir Immune Defic Syndr. 2018 Apr 1;77(4):417-426. doi: 10.1097/QAI.0000000000001619.
Paul R, Prasitsuebsai W, Jahanshad N, Puthanakit T, Thompson P, Aurpibul L, Hansudewechakul R, Kosalaraksa P, Kanjanavanit S, Ngampiyaskul C, Luesomboon W, Lerdlum S, Pothisri M, Visrutaratna P, Valcour V, Nir TM, Saremi A, Kerr S, Ananworanich J; Pediatric Randomized Early versus Deferred Initiation in Cambodia and Thailand (PREDICT) Study Group. Structural Neuroimaging and Neuropsychologic Signatures in Children With Vertically Acquired HIV. Pediatr Infect Dis J. 2018 Jul;37(7):662-668. doi: 10.1097/INF.0000000000001852.
Bunupuradah T, Hansudewechakul R, Kosalaraksa P, Ngampiyaskul C, Kanjanavanit S, Wongsawat J, Luesomboon W, Sophonphan J, Puthanakit T, Ruxrungtham K, Shearer WT, Ananworanich J; PREDICT study group. HLA-DRB1454 and predictors of new-onset asthma in HIV-infected Thai children. Clin Immunol. 2015 Mar;157(1):26-9. doi: 10.1016/j.clim.2014.12.006. Epub 2014 Dec 26. No abstract available.
Intasan J, Bunupuradah T, Vonthanak S, Kosalaraksa P, Hansudewechakul R, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Apornpong T, Kerr S, Ananworanich J, Puthanakit T; PREDICT Study Group. Comparison of adherence monitoring tools and correlation to virologic failure in a pediatric HIV clinical trial. AIDS Patient Care STDS. 2014 Jun;28(6):296-302. doi: 10.1089/apc.2013.0276.
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; 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 Dec;12(12):933-41. doi: 10.1016/S1473-3099(12)70242-6. Epub 2012 Oct 9.
Kosalaraksa P, Bunupuradah T, Vonthanak S, Wiangnon S, Hansudewechakul R, Vibol U, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Lumbiganon P, Sopa B, Apornpong T, Chuenyam T, Cooper DA, Ruxrungtham K, Ananworanich J, Puthanakit T. Prevalence of anemia and underlying iron status in naive antiretroviral therapy HIV-infected children with moderate immune suppression. AIDS Res Hum Retroviruses. 2012 Dec;28(12):1679-86. doi: 10.1089/AID.2011.0373. Epub 2012 Jul 25.
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. doi: 10.1038/ejcn.2012.57. Epub 2012 Jun 20.
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. doi: 10.3851/IMP1897.
Bunupuradah T, Puthanakit T, Kosalaraksa P, Kerr SJ, Kariminia A, Hansudewechakul R, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Chuenyam T, Vonthanak S, Vun MC, Vibol U, Vannary B, Ruxrungtham K, Ananworanich J; PREDICT Study Group. Poor quality of life among untreated Thai and Cambodian children without severe HIV symptoms. AIDS Care. 2012;24(1):30-8. doi: 10.1080/09540121.2011.592815. Epub 2011 Jul 21.
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 12 years of age. J Allergy Clin Immunol. 2010 Dec;126(6):1294-301.e10. doi: 10.1016/j.jaci.2010.09.038.
Wongsawat J, Puthanakit T, Kanjanavanit S, Hansudewechakul R, Ngampiyaskul C, Kerr SJ, Ubolyam S, Suwanlerk T, Kosalaraksa P, Luesomboon W, Ngo-Giang-Huong N, Chandara M, Saphonn V, Ruxrungtham K, Ananworanich J; PREDICT Study Group. CD4 cell count criteria to determine when to initiate antiretroviral therapy in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2010 Oct;29(10):966-8. doi: 10.1097/INF.0b013e3181e0554c.
Related Links
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Click here for more information about the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Other Identifiers
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PREDICT
Identifier Type: -
Identifier Source: secondary_id
10409
Identifier Type: REGISTRY
Identifier Source: secondary_id
CIPRA TH001
Identifier Type: -
Identifier Source: org_study_id