When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)
This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Comprehensive International Program of Research on AIDS
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00234091
First received: October 4, 2005
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
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 |
|---|---|---|
|
HIV Infections |
Drug: Abacavir Drug: Efavirenz Drug: Lamivudine Drug: Lopinavir/Ritonavir Drug: Nelfinavir Drug: Nevirapine Drug: Zidovudine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Zidovudine
Nevirapine
Lamivudine
Abacavir
Efavirenz
Ritonavir
Nelfinavir
Nelfinavir Mesylate
Abacavir sulfate
Lopinavir
U.S. FDA Resources
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- AIDS-free survival [ Time Frame: Week 144 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Direct and indirect cost of treatment per patient [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
- Number and duration of hospitalizations [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Time to and number of Grades 3 or 4 HAART-related toxicity and intolerance [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Number of HAART regimen changes [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Number of Grades 1 or 2 infectious episodes [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Number of courses of antibiotics used [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Number of HIV-related clinical events [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Virologic failure, defined as HIV viral load of 1000 copies/ml [ Time Frame: Week 24 after HAART initiation ] [ Designated as safety issue: No ]
- Presence of a resistance mutation in participants with virologic failure [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Change of growth in Z scores [ Time Frame: study entry to Week 144 ] [ Designated as safety issue: No ]
- Change in CD4% and time-weighted average change [ Time Frame: study entry and Week 144 ] [ Designated as safety issue: No ]
- CD4 less than 10% [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
- Average scores of the child's quality of life over time [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
- Percentage adherence to HAART over time by pill count/weighing liquid medication bottles, self report, and questionnaire [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Presence of iron deficiency anemia [ Time Frame: study entry and Weeks 24, 48, 72, 96, 120, and 144 ] [ Designated as safety issue: No ]
- HIV viral sequence [ Time Frame: study entry and treatment failure ] [ Designated as safety issue: No ]
- HIV viral replication capacity [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Cytotoxic T-cell (CTL) response [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Percentage of different T-cell subsets [ Time Frame: study entry and Weeks 48, 96, and 144 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Immediate treatment; individuals receive HAART on Day 1 of the study
|
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)
|
|
Active Comparator: 2
Delayed treatment; individuals receive HAART if their CD4 percentage falls below 15 percentage OR if they develop a CDC category C illness
|
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)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 1 Year to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234091
Locations
| Cambodia | |
| 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 | |
| The HIV Netherlands Australia Thailand Research Collaborative 104 Rajdumri Road, | |
| Pathumwan, Bangkok, Thailand, 10330 | |
| Nakornping Hospital 159 Moo 10, Tambon Donkaew | |
| Mae Rim, Chiang Mai, Thailand, 50180, | |
| Chiangrai Regional Hospital 1039 Satanpayaban Road | |
| Muang, Chiang Rai, Thailand, 57000 | |
| Queen Savang Vadhana Memorial Hospital, 290 Choemchompol Road, | |
| Siracha, Chonburi, Thailand, 20110 | |
| Prapokklao Hospital, 38 Leibnern Road | |
| Chantaburi, Thailand, 22000 | |
| Thailand Study Coordination Center, 29/7-8 Samlan Road, Soi-1 Prasing | |
| Chiang Mai, Thailand, 50200 | |
| Srinagarind Hospital | |
| Khon Kaen, Thailand | |
| Srinagarind Hospital, Khon Kaen University, 123 Mitraparb Road | |
| Khon Kaen, Thailand, 40002 | |
| Barasnaradura Institute 126 Tiwanond Road | |
| Nonthaburi, Thailand, 11000 | |
Sponsors and Collaborators
Comprehensive International Program of Research on AIDS
Investigators
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00234091 History of Changes |
| Other Study ID Numbers: | CIPRA TH001, PREDICT, 10483 |
| Study First Received: | October 4, 2005 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Nevirapine Lamivudine Efavirenz |
Abacavir Ritonavir Nelfinavir Lopinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013