Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039741
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2002-06-07
Brief Title:
Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IIIII Randomized Open-Label Study of Combination Antiretroviral Regimens and Treatment-Switching Strategies in HIV-1-Infected Antiretroviral Naive Children Between 30 Days and 18 Years of Age
Status:
COMPLETED
Status Verified Date:
2019-01
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:
Little is known about what treatment combinations are best for HIV infected children This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work The study enrolled children who had not previously taken anti-HIV medication Participants in this study were recruited in the United States South America and Europe
Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications
Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications
Detailed Description:
Antiretroviral therapy in children aims to prolong clinical and immunologic health Currently there are no data defining a particular highly active antiretroviral therapy HAART strategy as the optimal first-line therapy for children This study evaluated the long-term efficacy of two HAART regimens used as initial therapy 1 two nucleoside reverse transcriptase inhibitors NRTIs plus a protease inhibitor PI and 2 two NRTIs plus a nonnucleoside reverse transcriptase inhibitor NNRTI It also evaluated different strategies for switching therapy when the initial regimen fails The long-term nature of this study should clarify whether early switching of therapy improves immunologic and virologic outcomes or results in a more rapid exhaustion of treatment options The study was conducted in the United States and in Europe
Participants in this study had a CD4 cell count and viral load test during a screening visit Participants had an entry visit that included blood and urine tests Participants were then randomly assigned to one of four groups Groups PI1K and PI30K received two NRTIs plus a PI Groups NNRTI1K and NNRTI30K received two NRTIs plus an NNRTI The medications allowed in the study were abacavir didanosine emtricitabine emtricitabinetenofovir disoproxil fumarate lamivudine lamivudinezidovudine stavudine tenofovir disoproxil fumarate zalcitabine and zidovudine NRTIs efavirenz and nevirapine NNRTIs efavirenzemtricitabinetenofovir disoproxil fumurate NNRTINRTI and amprenaviratazanavir darunavir fosamprenavir calcium indinavir lopinavirritonavir nelfinavir saquinavir ritonavir and tipranavir PIs Note Per the 062805 amendment of this trial emtricitabine emtricitabinetenofovir disoproxil fumarate and tenofovir dioproxil fumarate were added to the list of medications that could be included in a participants treatment regimen
For participants whose initial regimen failed or who experienced clinical disease progression indicated by the development of a new CDC Category C diagnosis or other clinical disease progression at or after Week 24 of first-line therapy second-line therapy was strongly encouraged However if poor adherence was suspected as a possible reason for an increase in HIV viral load the site and the clinician were to try to improve patient adherence and obtain additional confirmatory viral load values within a five-week time frame In second-line therapy participants who initially took NRTIs with a PI switched to NRTIs and an NNRTI Participants who initially took NRTIs and an NNRTI switched to NRTIs and a PI The timing of the switch was based on the participants group Groups PI1K and NNRTI1K switched to second-line treatment when viral load was 1000 copiesml or greater Groups PI30K and NNRTI30K switched to second-line treatment when viral load was 30000 copiesml or greater Participants who failed second-line therapy discontinued study treatment and were offered the best available therapy at the discretion of the clinician
Participants had study visits at Weeks 2 4 8 12 16 24 and every 12 weeks thereafter until the drug regimen was switched to second-line treatment Participants then had a re-entry visit and the schedule of visits restarted Participants were in the study between 4 and 7 years depending on when they enrolled All study visits included medical history a physical exam and blood collection Urine collection occurred at most visits Participants were asked to complete adherence questionnaires and PACTG participants underwent neuropsychological assessments at selected visits
All participants in this study were encouraged to coenroll in PACTG 219C Long-Term Effects of HIV Exposure and Infection in Children Participants in the European portion of the study may be asked to enroll in a substudy to observe the development and progression of lipodystrophy syndrome in children
Participants in this study had a CD4 cell count and viral load test during a screening visit Participants had an entry visit that included blood and urine tests Participants were then randomly assigned to one of four groups Groups PI1K and PI30K received two NRTIs plus a PI Groups NNRTI1K and NNRTI30K received two NRTIs plus an NNRTI The medications allowed in the study were abacavir didanosine emtricitabine emtricitabinetenofovir disoproxil fumarate lamivudine lamivudinezidovudine stavudine tenofovir disoproxil fumarate zalcitabine and zidovudine NRTIs efavirenz and nevirapine NNRTIs efavirenzemtricitabinetenofovir disoproxil fumurate NNRTINRTI and amprenaviratazanavir darunavir fosamprenavir calcium indinavir lopinavirritonavir nelfinavir saquinavir ritonavir and tipranavir PIs Note Per the 062805 amendment of this trial emtricitabine emtricitabinetenofovir disoproxil fumarate and tenofovir dioproxil fumarate were added to the list of medications that could be included in a participants treatment regimen
For participants whose initial regimen failed or who experienced clinical disease progression indicated by the development of a new CDC Category C diagnosis or other clinical disease progression at or after Week 24 of first-line therapy second-line therapy was strongly encouraged However if poor adherence was suspected as a possible reason for an increase in HIV viral load the site and the clinician were to try to improve patient adherence and obtain additional confirmatory viral load values within a five-week time frame In second-line therapy participants who initially took NRTIs with a PI switched to NRTIs and an NNRTI Participants who initially took NRTIs and an NNRTI switched to NRTIs and a PI The timing of the switch was based on the participants group Groups PI1K and NNRTI1K switched to second-line treatment when viral load was 1000 copiesml or greater Groups PI30K and NNRTI30K switched to second-line treatment when viral load was 30000 copiesml or greater Participants who failed second-line therapy discontinued study treatment and were offered the best available therapy at the discretion of the clinician
Participants had study visits at Weeks 2 4 8 12 16 24 and every 12 weeks thereafter until the drug regimen was switched to second-line treatment Participants then had a re-entry visit and the schedule of visits restarted Participants were in the study between 4 and 7 years depending on when they enrolled All study visits included medical history a physical exam and blood collection Urine collection occurred at most visits Participants were asked to complete adherence questionnaires and PACTG participants underwent neuropsychological assessments at selected visits
All participants in this study were encouraged to coenroll in PACTG 219C Long-Term Effects of HIV Exposure and Infection in Children Participants in the European portion of the study may be asked to enroll in a substudy to observe the development and progression of lipodystrophy syndrome in children
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 |
|---|---|---|---|
| PENTA 9PACTG 390 | Registry Identifier | DAIDS ES | None |
| PENPACT-1B | None | None | None |
| 10106 | REGISTRY | None | None |