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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00234091 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Abacavir Drug: Efavirenz Drug: Lamivudine Drug: Lopinavir/Ritonavir Drug: Nelfinavir Drug: Nevirapine Drug: Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Open Label, Randomized Study to Compare Antiretroviral Therapy (ART) Initiation When CD4 is Between 15% to 24% to ART Initiation When CD4 Falls Below 15% in Children With HIV Infection and Moderate Immune Suppression |
Estimated Enrollment: | 300 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Immediate treatment; individuals receive HAART on Day 1 of the study
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Drug: Abacavir
8 mg/kg (up to 300 mg/dose) take orally twice daily
Drug: Efavirenz
200 to 600 mg taken orally once daily
Drug: Lamivudine
4 mg/kg (up to 150 mg/dose) taken orally twice daily
Drug: Lopinavir/Ritonavir
230 mg/57.5 mg/m^2 body surface area taken orally twice daily with food
Drug: Nelfinavir
45-55 mg/kg taken orally twice daily with food
Drug: Nevirapine
120 mg/m^2 once daily for first 14 days, tehn 200 mg/m^2 (up to 400 mg/day) twice daily
Drug: Zidovudine
180-240 mg/m^2 every 12 hours (up to 300 mg/dose)
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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
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Drug: Abacavir
8 mg/kg (up to 300 mg/dose) take orally twice daily
Drug: Efavirenz
200 to 600 mg taken orally once daily
Drug: Lamivudine
4 mg/kg (up to 150 mg/dose) taken orally twice daily
Drug: Lopinavir/Ritonavir
230 mg/57.5 mg/m^2 body surface area taken orally twice daily with food
Drug: Nelfinavir
45-55 mg/kg taken orally twice daily with food
Drug: Nevirapine
120 mg/m^2 once daily for first 14 days, tehn 200 mg/m^2 (up to 400 mg/day) twice daily
Drug: Zidovudine
180-240 mg/m^2 every 12 hours (up to 300 mg/dose)
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The use of highly active antiretroviral therapy (HAART) has resulted in a significant reduction in AIDS-related deaths and complications among adults and adolescents. However, the medical management of HIV infected children remains challenging. Access to HIV treatment is limited and early treatment initiation can cause serious complications. Since there is currently no cure for HIV, a balance between treating the disease and maintaining quality of life must be weighed carefully. An evaluation to determine the appropriate time to initiate HAART is necessary to improve both quality of life and survival for HIV infected children.
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.
Ages Eligible for Study: | 1 Year to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Cambodia, Phnom Penh | |
National Pediatric Hospital | |
100 Federation of Russia Blvd, Phnom Penh, Cambodia | |
Social Health Clinic, National Center for HIV/AIDS, Dermatology, and STDs | |
#170, Preah Sihanouk Blvd, Phnom Penh, Cambodia | |
Thailand | |
Srinagarind Hospital | |
Khon Kaen, Thailand | |
Thailand, Bangkok | |
The HIV Netherlands Australia Thailand Research Collaborative | |
104 Rajdumri Road, Pathumwan, Bangkok, Thailand, 10330 | |
Thailand, Chantaburi | |
Prapokklao Hospital | |
38 Leibnern Road, Chantaburi, Thailand, 22000 | |
Thailand, Chiang Mai | |
Nakornping Hospital | |
159 Moo 10, Tambon Donkaew, Mae Rim, Chiang Mai, Thailand, 50180, | |
Thailand Study Coordination Center | |
29/7-8 Samlan Road, Soi-1 Prasing, Chiang Mai, Thailand, 50200 | |
Thailand, Chiang Rai | |
Chiangrai Regional Hospital | |
1039 Satanpayaban Road Muang, Chiang Rai, Thailand, 57000 | |
Thailand, Chonburi | |
Queen Savang Vadhana Memorial Hospital | |
290 Choemchompol Road, Siracha, Chonburi, Thailand, 20110 | |
Thailand, Khon Kaen | |
Srinagarind Hospital, Khon Kaen University | |
123 Mitraparb Road, Khon Kaen, Thailand, 40002 | |
Thailand, Nonthaburi | |
Barasnaradura Institute | |
126 Tiwanond Road, Nonthaburi, Thailand, 11000 |
Study Chair: | 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 |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | CIPRA TH001, PREDICT |
Study First Received: | October 4, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00234091 |
Health Authority: | United States: Federal Government |
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 |
Efavirenz Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Immunologic Deficiency Syndromes Virus Diseases Nevirapine |
Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Abacavir Nelfinavir Retroviridae Infections |
Antimetabolites Anti-Infective Agents Communicable Diseases HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |