Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016718
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2001-05-31
Brief Title:
Safety and Effectiveness of Emtricitabine Efavirenz and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Study to Evaluate the Safety Tolerance Antiviral Activity and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors NRTIs and 1 protease inhibitor PI For children this regimen may be too complicated or the drugs may be too difficult to take by mouth The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine ddI efavirenz EFV and emtricitabine FTC in pediatric patients who had taken few or no anti-HIV drugs
Detailed Description:
Anti-HIV treatment options are limited for pediatric patients because combination therapies recommended for adults may not be appropriate for children or adolescents Few PIs are available in formulations appropriate for pediatric patients and complex dosing schedules and food requirements may be detrimental to treatment adherence A once-daily regimen of the NRTIs ddI and FTC and the nonnucleoside reverse transcriptase inhibitor NNRTI EFV has been shown safe and well tolerated in adults
This Phase III open label study evaluated the long-term safety and efficacy of a ddI FTC and EFV regimen in pediatric patients All study patients were either absolutely naive to antiretroviral therapy or had received less than or equal to 56 days perinatal prophylaxis or less than 7 days of cumulative antiretroviral therapy prior to study entry and had a plasma screening plasma HIV-1 RNA levels 5000 copiesmL This study was written to characterize the disposition of FTC determine the PK data for ddI-EC QD comparing the bio-availability of the enteric coated formulation with ddI pediatric powder for oral solution and to provide insight into the age related pharmacokinetics differences observed in this and other studies
HIV infected pediatric patients were stratified into three age Groups Group 1 90 days to 3 years of age Group 2 3 years to 12 years of age inclusive and Group 3 13 to 21 years of age inclusive The initial study doses for the triple drug regimen was FTC 6 mkkg up to a maximum of 200 mg once daily for EFV the dose for age Group 1 was determined in PACTG 382 and dose adjusted for body size and the doses for age Groups 2 and 3 were defined in the dosing table of the protocol of up to a maximum of 600 mg once daily as a capsule or 720 mg as an oral solution for ddI 240 mgm2 up to a maximum of 400 mg once daily Comparison of age groups was not required as per the protocol
Patients were followed for a maximum of 192 weeks all patients were to receive ddI EFV and FTC together once daily Study visits occurred at study entry Weeks 2and 4 and every 4 weeks thereafter Blood collection medical history assessment and a physical exam occurred at all visits urine collection occurred at selected visits Intensive pharmacokinetic PK studies was done at Weeks 2 and 12 to determine if dose adjustments were required for any of the drugs If virologic failure was determined PK studies was repeated 4 weeks after adjustments in therapy Parents or guardians were asked to complete treatment adherence questionnaires at some visits Some patients were also asked to participate in an additional PK study after Week 16 or week 96
This Phase III open label study evaluated the long-term safety and efficacy of a ddI FTC and EFV regimen in pediatric patients All study patients were either absolutely naive to antiretroviral therapy or had received less than or equal to 56 days perinatal prophylaxis or less than 7 days of cumulative antiretroviral therapy prior to study entry and had a plasma screening plasma HIV-1 RNA levels 5000 copiesmL This study was written to characterize the disposition of FTC determine the PK data for ddI-EC QD comparing the bio-availability of the enteric coated formulation with ddI pediatric powder for oral solution and to provide insight into the age related pharmacokinetics differences observed in this and other studies
HIV infected pediatric patients were stratified into three age Groups Group 1 90 days to 3 years of age Group 2 3 years to 12 years of age inclusive and Group 3 13 to 21 years of age inclusive The initial study doses for the triple drug regimen was FTC 6 mkkg up to a maximum of 200 mg once daily for EFV the dose for age Group 1 was determined in PACTG 382 and dose adjusted for body size and the doses for age Groups 2 and 3 were defined in the dosing table of the protocol of up to a maximum of 600 mg once daily as a capsule or 720 mg as an oral solution for ddI 240 mgm2 up to a maximum of 400 mg once daily Comparison of age groups was not required as per the protocol
Patients were followed for a maximum of 192 weeks all patients were to receive ddI EFV and FTC together once daily Study visits occurred at study entry Weeks 2and 4 and every 4 weeks thereafter Blood collection medical history assessment and a physical exam occurred at all visits urine collection occurred at selected visits Intensive pharmacokinetic PK studies was done at Weeks 2 and 12 to determine if dose adjustments were required for any of the drugs If virologic failure was determined PK studies was repeated 4 weeks after adjustments in therapy Parents or guardians were asked to complete treatment adherence questionnaires at some visits Some patients were also asked to participate in an additional PK study after Week 16 or week 96
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IMPAACT P1021 | Registry Identifier | DAIDS ES | None |
| 10038 | REGISTRY | None | None |
| ACTG P1021 | None | None | None |
| PACTG P1021 | None | None | None |