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NCT00234091 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00234091
Other study ID # CIPRA TH001
Secondary ID PREDICT10409
Status Completed
Phase Phase 3
First received October 4, 2005
Last updated December 2, 2013
Start date April 2006
Est. completion date September 2011

Study information
Verified date December 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 12 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Abacavir
8 mg/kg (up to 300 mg/dose) take orally twice daily
• Efavirenz
200 to 600 mg taken orally once daily
• Lamivudine
4 mg/kg (up to 150 mg/dose) taken orally twice daily
• Lopinavir/Ritonavir
230 mg/57.5 mg/m^2 body surface area taken orally twice daily with food
• Nelfinavir
45-55 mg/kg taken orally twice daily with food
• Nevirapine
120 mg/m^2 once daily for first 14 days, tehn 200 mg/m^2 (up to 400 mg/day) twice daily
• Zidovudine
180-240 mg/m^2 every 12 hours (up to 300 mg/dose)

Locations
Country Name City State
Cambodia National Pediatric Hosp., Cambodia CIPRA CRS Phnom Penh
Cambodia Social Health Clinic, Cambodia CIPRA CRS Phnom Penh
Thailand Prapokklao Hosp. CIPRA CRS Chantaburi
Thailand Nakornping Hosp. CIPRA CRS Chiang Mai
Thailand Queen Savang Vadhana Memorial Hosp. CIPRA CRS Chonburi
Thailand Srinagarind Hosp. CIPRA CRS Khon Kaen
Thailand Chiang Rai Regional Hosp. CIPRA CRS Muang Chiang Rai
Thailand Bamrasnaradura Institute CIPRA CRS Nonthaburi
Thailand Hiv-Nat Cipra Crs Pathumwan Bangkok

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Comprehensive International Program of Research on AIDS

Countries where clinical trial is conducted

Cambodia,  Thailand, 

References & Publications (4)

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. Epub 2007 Feb 12. — View Citation

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. Epub 2002 Jan 8. — View Citation

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. Epub 2007 Jan 9. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary AIDS-free survival Week 144 Yes
Secondary Direct and indirect cost of treatment per patient Week 144 No
Secondary Number and duration of hospitalizations throughout study No
Secondary Time to and number of Grades 3 or 4 HAART-related toxicity and intolerance throughout study Yes
Secondary Number of HAART regimen changes throughout study No
Secondary Number of Grades 1 or 2 infectious episodes throughout study No
Secondary Number of courses of antibiotics used throughout study No
Secondary Number of HIV-related clinical events throughout study No
Secondary Virologic failure, defined as HIV viral load of 1000 copies/ml Week 24 after HAART initiation No
Secondary Presence of a resistance mutation in participants with virologic failure throughout study No
Secondary Change of growth in Z scores study entry to Week 144 No
Secondary Change in CD4% and time-weighted average change study entry and Week 144 No
Secondary CD4 less than 10% Week 144 No
Secondary Average scores of the child's quality of life over time Week 144 No
Secondary Percentage adherence to HAART over time by pill count/weighing liquid medication bottles, self report, and questionnaire throughout study No
Secondary Presence of iron deficiency anemia study entry and Weeks 24, 48, 72, 96, 120, and 144 No
Secondary HIV viral sequence study entry and treatment failure No
Secondary HIV viral replication capacity throughout study No
Secondary Cytotoxic T-cell (CTL) response throughout study No
Secondary Percentage of different T-cell subsets study entry and Weeks 48, 96, and 144 No
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