When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

NCT00234091 | Completed Phase 3

• 3 other identifiers: CIPRA TH001PREDICT10409
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival.

Conditions

HIV Infections

Keywords

Treatment Naive; Treatment Initiation; Infant; Preschool Child; Child; Zidovudine; AZT; Retrovir; 3TC; Lamivudine; Epivir; Nevirapine; NVP; Viramune; Efavirenz; EFV; Sustiva; Lopinavir/Ritonavir; LPV/r; Kaletra; Nelfinavir; NFV; Viracept; ABC; Abacavir; Ziagen

Outcome Measures

Primary Outcomes (1)

• AIDS-free survival

  Week 144

Secondary Outcomes (19)

• Direct and indirect cost of treatment per patient

  Week 144

• Number and duration of hospitalizations

  throughout study

• Time to and number of Grades 3 or 4 HAART-related toxicity and intolerance

  throughout study

• Number of HAART regimen changes

  throughout study

• Number of Grades 1 or 2 infectious episodes

  throughout study

Study Arms (2)

1

ACTIVE COMPARATOR

Immediate treatment; individuals receive HAART on Day 1 of the study

Drug: Abacavir; Drug: Efavirenz; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nelfinavir; Drug: Nevirapine; Drug: Zidovudine

2

ACTIVE COMPARATOR

Delayed treatment; individuals receive HAART if their CD4 percentage falls below 15 percentage OR if they develop a CDC category C illness

Drug: Abacavir; Drug: Efavirenz; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nelfinavir; Drug: Nevirapine; Drug: Zidovudine

Interventions

Abacavir DRUG

8 mg/kg (up to 300 mg/dose) take orally twice daily

1; 2

Efavirenz DRUG

200 to 600 mg taken orally once daily

1; 2

Lamivudine DRUG

4 mg/kg (up to 150 mg/dose) taken orally twice daily

1; 2

Lopinavir/Ritonavir DRUG

230 mg/57.5 mg/m\^2 body surface area taken orally twice daily with food

1; 2

Nelfinavir DRUG

45-55 mg/kg taken orally twice daily with food

1; 2

Nevirapine DRUG

120 mg/m\^2 once daily for first 14 days, tehn 200 mg/m\^2 (up to 400 mg/day) twice daily

1; 2

Zidovudine DRUG

180-240 mg/m\^2 every 12 hours (up to 300 mg/dose)

1; 2

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• HIV-1 infected
• 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

You may not qualify if:

• Use of systemic chemotherapy, immunomodulators, HIV vaccines, immune globulin, interleukins, or interferons within 30 days prior to study entry
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Comprehensive International Program of Research on AIDS: collaborator

Study Sites (9)

National Pediatric Hosp., Cambodia CIPRA CRS

Phnom Penh, Cambodia

Location

Social Health Clinic, Cambodia CIPRA CRS

Phnom Penh, Cambodia

Location

Hiv-Nat Cipra Crs

Pathumwan, Bangkok, 10330, Thailand

Location

Chiang Rai Regional Hosp. CIPRA CRS

Muang, Changwat Chiang Rai, 57000, Thailand

Location

Prapokklao Hosp. CIPRA CRS

Chanthaburi, 22000, Thailand

Location

Nakornping Hosp. CIPRA CRS

Chiang Mai, 50180, Thailand

Location

Queen Savang Vadhana Memorial Hosp. CIPRA CRS

Chon Buri, 20110, Thailand

Location

Srinagarind Hosp. CIPRA CRS

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Institute CIPRA CRS

Nonthaburi, 11000, Thailand

Location

Related Publications (16)

• 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.

  PMID: 17296781 BACKGROUND

• 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.

  PMID: 11807710 BACKGROUND

• 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.

  PMID: 17243067 BACKGROUND

• 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.

  PMID: 15353977 BACKGROUND

• 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.

  PMID: 31895148 DERIVED

• 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.

  PMID: 29303843 DERIVED

• 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.

  PMID: 29200184 DERIVED

• 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.

  PMID: 25546395 DERIVED

• 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.

  PMID: 24901463 DERIVED

• 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.

  PMID: 23059199 DERIVED

• 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.

  PMID: 22734817 DERIVED

• 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.

  PMID: 22713768 DERIVED

• 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.

  PMID: 22155918 DERIVED

• 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.

  PMID: 21777076 DERIVED

• 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.

  PMID: 21134574 DERIVED

• 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.

  PMID: 20418798 DERIVED

Related Links

• Click here for more information about the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir; efavirenz; Lamivudine; Lopinavir; Nelfinavir; Nevirapine; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Pyrimidinones; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Thymidine

Study Officials

• Kiat Ruxrungtham, MD, MPH

  Department of Medicine at Chulalongkorn University, Bangkok, Thailand

  STUDY CHAIR

• Saphonn Vonthanak, MD, PhD

  National Center for HIV/AIDS Dermatology and STDs, Phnom Penh, Cambodia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: April 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

CA (2); TH (7)