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AzTrials

HIV InfectionsPhase 3NCT00234091

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

A Phase 3 study testing Abacavir, Efavirenz and Lamivudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 12 years
Conditions the study is for
HIV Infections
What is being tested?
Abacavir, Efavirenz and Lamivudine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
9 sitesin 2 countries
Study dates
Apr 2006to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Thailand7 sites

  • Prapokklao Hosp. CIPRA CRS

    Chanthaburi, 22000

  • Nakornping Hosp. CIPRA CRS

    Chiang Mai, 50180

  • Queen Savang Vadhana Memorial Hosp. CIPRA CRS

    Chon Buri, 20110

  • Srinagarind Hosp. CIPRA CRS

    Khon Kaen, 40002

  • Chiang Rai Regional Hosp. CIPRA CRS

    Muang, Changwat Chiang Rai, 57000

  • Bamrasnaradura Institute CIPRA CRS

    Nonthaburi, 11000

  • Hiv-Nat Cipra Crs

    Pathumwan, Bangkok, 10330

Other trials in Thailand

Cambodia2 sites

  • National Pediatric Hosp., Cambodia CIPRA CRS

    Phnom Penh

  • Social Health Clinic, Cambodia CIPRA CRS

    Phnom Penh

Other trials in Cambodia

About this 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

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.

Read the 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.

Conditions
HIV Infections
Being tested
Abacavir, Efavirenz, Lamivudine, Lopinavir/Ritonavir, Nelfinavir
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
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbacavirDrug

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

  • EfavirenzDrug

    200 to 600 mg taken orally once daily

  • LamivudineDrug

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

  • Lopinavir/RitonavirDrug

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

  • NelfinavirDrug

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

  • NevirapineDrug

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

  • ZidovudineDrug

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

Study groups in NCT00234091
Study groupRoleWhat they receive
1Active comparatorImmediate treatment; individuals receive HAART on Day 1 of the study
Receives: Drug: Abacavir; Drug: Efavirenz; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nelfinavir; Drug: Nevirapine; Drug: Zidovudine
2Active comparatorDelayed treatment; individuals receive HAART if their CD4 percentage falls below 15 percentage OR if they develop a CDC category C illness
Receives: Drug: Abacavir; Drug: Efavirenz; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nelfinavir; Drug: Nevirapine; Drug: Zidovudine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AIDS-free survival

    Measured: Week 144

Secondary outcomes (19)

  1. Direct and indirect cost of treatment per patient

    Measured: Week 144

  2. Number and duration of hospitalizations

    Measured: throughout study

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

    Measured: throughout study

  4. Number of HAART regimen changes

    Measured: throughout study

  5. Number of Grades 1 or 2 infectious episodes

    Measured: throughout study

  6. Number of courses of antibiotics used

    Measured: throughout study

  7. Number of HIV-related clinical events

    Measured: throughout study

  8. Virologic failure, defined as HIV viral load of 1000 copies/ml

    Measured: Week 24 after HAART initiation

  9. Presence of a resistance mutation in participants with virologic failure

    Measured: throughout study

  10. Change of growth in Z scores

    Measured: study entry to Week 144

  11. Change in CD4% and time-weighted average change

    Measured: study entry and Week 144

  12. CD4 less than 10%

    Measured: Week 144

  13. Average scores of the child's quality of life over time

    Measured: Week 144

  14. Percentage adherence to HAART over time by pill count/weighing liquid medication bottles, self report, and questionnaire

    Measured: throughout study

  15. Presence of iron deficiency anemia

    Measured: study entry and Weeks 24, 48, 72, 96, 120, and 144

  16. HIV viral sequence

    Measured: study entry and treatment failure

  17. HIV viral replication capacity

    Measured: throughout study

  18. Cytotoxic T-cell (CTL) response

    Measured: throughout study

  19. Percentage of different T-cell subsets

    Measured: study entry and Weeks 48, 96, and 144

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2005 (estimated)
  2. Study startApr 2006
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00234091
Sponsor's protocol ID
CIPRA TH001
Other IDs
PREDICT, 10409
Status last verified
Dec 2013
First submitted
4 Oct 2005
Last updated
4 Dec 2013
Results posted
No

Publications

  • 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.

    PubMed 17296781

  • 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.

    PubMed 11807710

  • 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.

    PubMed 17243067

  • 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.

    PubMed 15353977

  • 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.

    PubMed 31895148

  • 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.

    PubMed 29303843

  • 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.

    PubMed 29200184

  • 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.

    PubMed 25546395

  • 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.

    PubMed 24901463

  • 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.

    PubMed 23059199

  • 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.

    PubMed 22734817

  • 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.

    PubMed 22713768

  • 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.

    PubMed 22155918

  • 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.

    PubMed 21777076

  • 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.

    PubMed 21134574

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abacavir, Efavirenz and Lamivudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Thailand, Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AIDS-free survival (time frame: Week 144). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00234091, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.

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