Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001095
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Study of 1 Amprenavir 141W94VX478 Plus 3TC Plus ZDV or d4T or 2 IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3 Other Treatment Regimens Observational ARM in Subjects Previously Treated With Amprenavir
Status:
COMPLETED
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:
To determine the proportion of patients treated with amprenavir zidovudine ZDV stavudine D4T and lamivudine 3TC whose HIV-1 RNA level remains below the level of detection during 96 weeks of therapy To determine the proportion of patients treated with indinavir IDV nevirapine NVP 3TC and d4T whose HIV-1 RNA level decreases and then remains below the level of detection during the 96-week therapy period To determine the viral effects safety tolerability and pharmacokinetics of amprenavir in combination with zidovudine stavudine and lamivudine AS PER AMENDMENT 22798 To determine the proportion of patients with undetectable plasma HIV RNA by treatment and baseline RNA cohort either detectable or undetectable To determine the durability of these regimens by estimating the distribution of time to loss of virologic suppression or equivalently time to virologic failure by treatment and baseline RNA cohort This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir ZDV d4T and 3TC Additionally this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels treatment failures the opportunity to change to a potentially more active regimen that includes indinavir nevirapine lamivudine and stavudine
Detailed Description:
This study allows patients who have successfully participated in ACTG 347 or other trials involving amprenavir to continue treatment with amprenavir ZDV d4T and 3TC Additionally this study provides patients whose HIV-1 RNA was not reduced to undetectable levels or who had a significant increase in plasma levels treatment failures the opportunity to change to a potentially more active regimen that includes indinavir nevirapine lamivudine and stavudine
Patients with HIV RNA less than 500 copiesml on a regimen containing amprenavir are treated on Arm A those with greater than or equal to 500 copies while on or intolerant to a regimen containing amprenavir are treated on Arm B
Arm A Amprenavir ZDV d4T 3TC Arm B IND NVP 3TC d4T Patients enrolled in Arm A who fail therapy may roll over to Arm B Patients in Arm B who fail therapy discontinue study medications and seek best available treatment
AS PER AMENDMENT 22798 Patients with HIV RNA less than 500 copiesml currently on triple therapy with amprenavir 3TC ZDV or d4T if ZDV-intolerant are treated on ARM A Patients with HIV RNA greater than or equal to 500 copiesml who have been intolerant to a regimen containing amprenavir or who were previously enrolled on ACTG 347 who elected to receive a treatment regimen other than amprenavir ZDV or d4T 3TC or IDV NVP 3TC d4T or other regimens are assigned to Arm C
Arm A Amprenavir ZDV plus 3TC Arm B IDV NVP 3TC d4T Arm C Observation only Patients are followed for the duration of the study
Patients intolerant of ZDV may elect to receive d4T Patients intolerant of IDV may take study-provided nelfinavir Patients who switched to open-label IDVNVP3TCd4T prior to enrollment on this study and who were intolerant to any of the study medications may enroll into Arm B with appropriate substitution of the intolerant study drugs
Patients initially assigned to Arm A who are intolerant of amprenavir or who fail therapy have the option of receiving Arm B therapy Patients initially assigned to Arm B who are intolerant of any of the assigned study drugs may make an appropriate antiretroviral substitution with approval of the protocol chair
Patients with HIV RNA less than 500 copiesml on a regimen containing amprenavir are treated on Arm A those with greater than or equal to 500 copies while on or intolerant to a regimen containing amprenavir are treated on Arm B
Arm A Amprenavir ZDV d4T 3TC Arm B IND NVP 3TC d4T Patients enrolled in Arm A who fail therapy may roll over to Arm B Patients in Arm B who fail therapy discontinue study medications and seek best available treatment
AS PER AMENDMENT 22798 Patients with HIV RNA less than 500 copiesml currently on triple therapy with amprenavir 3TC ZDV or d4T if ZDV-intolerant are treated on ARM A Patients with HIV RNA greater than or equal to 500 copiesml who have been intolerant to a regimen containing amprenavir or who were previously enrolled on ACTG 347 who elected to receive a treatment regimen other than amprenavir ZDV or d4T 3TC or IDV NVP 3TC d4T or other regimens are assigned to Arm C
Arm A Amprenavir ZDV plus 3TC Arm B IDV NVP 3TC d4T Arm C Observation only Patients are followed for the duration of the study
Patients intolerant of ZDV may elect to receive d4T Patients intolerant of IDV may take study-provided nelfinavir Patients who switched to open-label IDVNVP3TCd4T prior to enrollment on this study and who were intolerant to any of the study medications may enroll into Arm B with appropriate substitution of the intolerant study drugs
Patients initially assigned to Arm A who are intolerant of amprenavir or who fail therapy have the option of receiving Arm B therapy Patients initially assigned to Arm B who are intolerant of any of the assigned study drugs may make an appropriate antiretroviral substitution with approval of the protocol chair
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 |
|---|---|---|---|
| 11334 | REGISTRY | DAIDS ES | None |