When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)
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ClinicalTrials.gov Identifier: NCT00234091 |
Recruitment Status
:
Completed
First Posted
: October 6, 2005
Last Update Posted
: December 4, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Abacavir Drug: Efavirenz Drug: Lamivudine Drug: Lopinavir/Ritonavir Drug: Nelfinavir Drug: Nevirapine Drug: Zidovudine | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
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)
|
- AIDS-free survival [ Time Frame: Week 144 ]
- Direct and indirect cost of treatment per patient [ Time Frame: Week 144 ]
- Number and duration of hospitalizations [ Time Frame: throughout study ]
- Time to and number of Grades 3 or 4 HAART-related toxicity and intolerance [ Time Frame: throughout study ]
- Number of HAART regimen changes [ Time Frame: throughout study ]
- Number of Grades 1 or 2 infectious episodes [ Time Frame: throughout study ]
- Number of courses of antibiotics used [ Time Frame: throughout study ]
- Number of HIV-related clinical events [ Time Frame: throughout study ]
- Virologic failure, defined as HIV viral load of 1000 copies/ml [ Time Frame: Week 24 after HAART initiation ]
- Presence of a resistance mutation in participants with virologic failure [ Time Frame: throughout study ]
- Change of growth in Z scores [ Time Frame: study entry to Week 144 ]
- Change in CD4% and time-weighted average change [ Time Frame: study entry and Week 144 ]
- CD4 less than 10% [ Time Frame: Week 144 ]
- Average scores of the child's quality of life over time [ Time Frame: Week 144 ]
- Percentage adherence to HAART over time by pill count/weighing liquid medication bottles, self report, and questionnaire [ Time Frame: throughout study ]
- Presence of iron deficiency anemia [ Time Frame: study entry and Weeks 24, 48, 72, 96, 120, and 144 ]
- HIV viral sequence [ Time Frame: study entry and treatment failure ]
- HIV viral replication capacity [ Time Frame: throughout study ]
- Cytotoxic T-cell (CTL) response [ Time Frame: throughout study ]
- Percentage of different T-cell subsets [ Time Frame: study entry and Weeks 48, 96, and 144 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234091
Cambodia | |
National Pediatric Hosp., Cambodia CIPRA CRS | |
Phnom Penh, Cambodia | |
Social Health Clinic, Cambodia CIPRA CRS | |
Phnom Penh, Cambodia | |
Thailand | |
Hiv-Nat Cipra Crs | |
Pathumwan, Bangkok, Thailand, 10330 | |
Chiang Rai Regional Hosp. CIPRA CRS | |
Muang, Chiang Rai, Thailand, 57000 | |
Prapokklao Hosp. CIPRA CRS | |
Chantaburi, Thailand, 22000 | |
Nakornping Hosp. CIPRA CRS | |
Chiang Mai, Thailand, 50180 | |
Queen Savang Vadhana Memorial Hosp. CIPRA CRS | |
Chonburi, Thailand, 20110 | |
Srinagarind Hosp. CIPRA CRS | |
Khon Kaen, Thailand, 40002 | |
Bamrasnaradura Institute CIPRA CRS | |
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 |
Additional Information:
Publications:
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 10409 ( Registry Identifier: DAIDS ES ) |
First Posted: | October 6, 2005 Key Record Dates |
Last Update Posted: | December 4, 2013 |
Last Verified: | December 2013 |
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:
Infection 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 Ritonavir Lopinavir Nelfinavir |
Lamivudine Zidovudine Nevirapine Abacavir Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |