Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000881
Status:
WITHDRAWN
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of Cidofovir in HIV-Infected Children With Cytomegalovirus CMV Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study of Cidofovir for HIV-Infected Children With Invasive CMV Cytomegalovirus Disease
Status:
WITHDRAWN
Status Verified Date:
2021-10
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:
Part A To determine the safety and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with end-organ cytomegalovirus CMV disease Part B To determine the safety including time to progression of CMV retinitis by retinal exam pharmacokinetics and long-term 6 months tolerance of multiple-dose cidofovir in HIV-infected children with CMV retinitis Part B To determine the effect of multiple-dose cidofovir on the virologic parameters of CMV retinitis viral load shedding and resistance to antiviral agents
AS PER AMENDMENT 1798 To determine the safety tolerance and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with CMV retinitis To determine the safety including time to progression of CMV retinitis by retinal exam pharmacokinetics and long-term 6-month tolerance of multiple doses of cidofovir in HIV-infected children with CMV retinitis While the intravenous formulation of cidofovir has been approved for the treatment of CMV retinitis in HIV-infected individuals information is limited regarding its safety and tolerance in HIV-infected children Intravenous cidofovir requires less frequent administration for both induction and maintenance therapy of CMV retinitis than other currently available therapies If found to be safe and well tolerated in HIV-infected children with CMV retinitis intravenous cidofovir would add significantly to agents available to treat this debilitating opportunistic infection
AS PER AMENDMENT 1798 To determine the safety tolerance and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with CMV retinitis To determine the safety including time to progression of CMV retinitis by retinal exam pharmacokinetics and long-term 6-month tolerance of multiple doses of cidofovir in HIV-infected children with CMV retinitis While the intravenous formulation of cidofovir has been approved for the treatment of CMV retinitis in HIV-infected individuals information is limited regarding its safety and tolerance in HIV-infected children Intravenous cidofovir requires less frequent administration for both induction and maintenance therapy of CMV retinitis than other currently available therapies If found to be safe and well tolerated in HIV-infected children with CMV retinitis intravenous cidofovir would add significantly to agents available to treat this debilitating opportunistic infection
Detailed Description:
While the intravenous formulation of cidofovir has been approved for the treatment of CMV retinitis in HIV-infected individuals information is limited regarding its safety and tolerance in HIV-infected children Intravenous cidofovir requires less frequent administration for both induction and maintenance therapy of CMV retinitis than other currently available therapies If found to be safe and well tolerated in HIV-infected children with CMV retinitis intravenous cidofovir would add significantly to agents available to treat this debilitating opportunistic infection
In this two-part study patients are stratified by age 3 months to 2 years versus 2 years to 13 years In Part A 8 patients 4 per cohort receive a single intravenous dose of cidofovir with concurrent probenecid If 1 patient in a cohort experiences life-threatening grade 34 toxicity accrual for that cohort is stopped If 1 patient in a cohort experiences non-life-threatening grade 34 toxicity 2 additional patients are entered in that cohort A second dose of cidofovir may be studied in Part A based on the pharmacokinetic and safety data obtained with the initial dose Patients who complete Part A of the study without serious toxicity may be treated in Part B
In Part B 12 patients 8 in the older cohort and 4 in the younger cohort receive maintenance therapy with cidofovir at the dose established in Part A Patients who complete 6 months of treatment in Part B may continue therapy until all patients have completed the study NOTE For patients who require induction or reinduction cidofovir is given weekly for 2 weeks before initiating the Part B regimen
AS PER AMENDMENT 1798 Each subject receives sequential single doses of intravenous cidofovir with a 2-week interval between doses and with concurrent probenecid If the single doses prove safe and well tolerated and individual pharmacokinetic profiles are acceptable subjects proceed to multi-dosing cidofovir given every 2 weeks for 6 months beginning 14-21 days after the second single dose Subjects remain on intravenous or oral ganciclovir for treatment of CMV retinitis until they enter the multi-dosing phase of the study Subjects who require reinduction during the multi-dosing phase receive intravenous cidofovir once weekly for 2 weeks before resuming the every-2-weeks regimen Patients are stratified by age 3 months to 2 years vs 2 years to 13 years with 4 patients entered in the younger cohort and 8 in the older In the younger age cohort if 1 patient experiences life- or vision-threatening grade 34 toxicity or 2 experience non-life-threatening grade 34 toxicity the age cohort will stop If 1 patient experiences non-life-threatening grade 34 toxicity 2 additional patients will be enrolled in this age cohort In the older age cohort if 1 patient experiences severe life- or vision-threatening toxicity or 2 experience serious non-life-threatening toxicities enrollment for both cohorts will be suspended while safety data are reviewed If 2 of the 8 patients experience severe non-life-threatening toxicity enrollment may continue
In this two-part study patients are stratified by age 3 months to 2 years versus 2 years to 13 years In Part A 8 patients 4 per cohort receive a single intravenous dose of cidofovir with concurrent probenecid If 1 patient in a cohort experiences life-threatening grade 34 toxicity accrual for that cohort is stopped If 1 patient in a cohort experiences non-life-threatening grade 34 toxicity 2 additional patients are entered in that cohort A second dose of cidofovir may be studied in Part A based on the pharmacokinetic and safety data obtained with the initial dose Patients who complete Part A of the study without serious toxicity may be treated in Part B
In Part B 12 patients 8 in the older cohort and 4 in the younger cohort receive maintenance therapy with cidofovir at the dose established in Part A Patients who complete 6 months of treatment in Part B may continue therapy until all patients have completed the study NOTE For patients who require induction or reinduction cidofovir is given weekly for 2 weeks before initiating the Part B regimen
AS PER AMENDMENT 1798 Each subject receives sequential single doses of intravenous cidofovir with a 2-week interval between doses and with concurrent probenecid If the single doses prove safe and well tolerated and individual pharmacokinetic profiles are acceptable subjects proceed to multi-dosing cidofovir given every 2 weeks for 6 months beginning 14-21 days after the second single dose Subjects remain on intravenous or oral ganciclovir for treatment of CMV retinitis until they enter the multi-dosing phase of the study Subjects who require reinduction during the multi-dosing phase receive intravenous cidofovir once weekly for 2 weeks before resuming the every-2-weeks regimen Patients are stratified by age 3 months to 2 years vs 2 years to 13 years with 4 patients entered in the younger cohort and 8 in the older In the younger age cohort if 1 patient experiences life- or vision-threatening grade 34 toxicity or 2 experience non-life-threatening grade 34 toxicity the age cohort will stop If 1 patient experiences non-life-threatening grade 34 toxicity 2 additional patients will be enrolled in this age cohort In the older age cohort if 1 patient experiences severe life- or vision-threatening toxicity or 2 experience serious non-life-threatening toxicities enrollment for both cohorts will be suspended while safety data are reviewed If 2 of the 8 patients experience severe non-life-threatening toxicity enrollment may continue
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11321 | REGISTRY | DAIDS ES | None |