Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000891
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy HAART in Subjects With Moderately Advanced HIV-1 Disease A Follow-Up Study to ACTG 315
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy HAART in Subjects With Moderately Advanced HIV-1 Disease A Follow-Up Study to ACTG 315
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 evaluate the relationship between viral suppression and changes in immune function as measured by the restoration of delayed-type hypersensitivity DTH and lymphoproliferative LP responses observed after 48 weeks of treatment with highly active antiretroviral therapy HAART in ACTG 315 To evaluate the durability of the antiviral and immunologic effects of long-term treatment with HAART
Given the extensive immunologic and virologic data available from ACTG 315 follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART
Given the extensive immunologic and virologic data available from ACTG 315 follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART
Detailed Description:
Given the extensive immunologic and virologic data available from ACTG 315 follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART
Patients continue their current ACTG 315 regimen of zidovudine plus lamivudine plus ritonavir in an open-label fashion while undergoing 6 weeks of extensive evaluations Treatment decisions are based on baseline viral load mean of 2 viral load measurements taken during 6-week evaluations Patients with HIV-1 RNA less than 100 copiesml continue the ACTG 315 regimen Patients with HIV-1 RNA 100-3000 copiesml may continue the ACTG 315 regimen or initiate a new HAART regimen selected by the local investigator or primary care physician Patients with HIV-1 RNA greater than 3000 copiesml initiate a new HAART regimen selected by the local investigator or primary care physician AS PER AMENDMENT 41000 Changes to regimens must be done in consultation with the study team The team acknowledges that a viable regimen may not be available for a given patient when the plasma HIV RNA level is above 3000 copiesml In this case patients may remain on their failing regimen with evaluation every 8 weeks until a viable regimen becomes available to them All patients are required to maintain a HAART regimen that contains at least 3 drugs 1 of which is a protease inhibitor AS PER AMENDMENT 3501 All patients are required to maintain a HAART regimen that is approved by the protocol chairs Zidovudine ZDV lamivudine 3TC stavudine d4T didanosine ddI delavirdine DLV ritonavir RTV and saquinavir soft gel capsules SQV sgc are provided on-study AS PER AMENDMENT 91900 ZDV 3TC 3TCZDV combination tablet d4T ddI DLV RTV and SQV sgc will be supplied by the protocol for 182 weeks AS PER AMENDMENT 3501 The following antiretroviral medications will be supplied by the protocol for Steps 1 and 2 ZDV 3TC 3TCZDV combination tablet d4T ddI DLV RTV and SQV sgc Therapy is continued for 54 weeks AS PER AMENDMENT 10698 The initial 54-week trial is followed by an additional 2 years of long-term evaluation Also per this amendment protocol therapy is initiated at Week 6 AS PER AMENDMENT 91900 The initial 54-week trial is followed by an additional 25 years of long-term evaluation AS PER AMENDMENT 3501 Step 1 has an initial 54 weeks of treatment followed by 140 weeks of long-term follow-up Step 2 has an additional 36 weeks of long-term follow-up Patients who complete the final visit on Step 2 Week 230 should return to the clinic 4 weeks after receiving the last dose of study-provided medication to complete the final evaluations AS PER AMENDMENT 10698 Patients may co-enroll in an immunology substudy AS PER AMENDMENT 61199 The immunology substudy is being piloted in 3 to 4 volunteers and may not proceed until the feasibility of the pilot project is reviewed
Patients continue their current ACTG 315 regimen of zidovudine plus lamivudine plus ritonavir in an open-label fashion while undergoing 6 weeks of extensive evaluations Treatment decisions are based on baseline viral load mean of 2 viral load measurements taken during 6-week evaluations Patients with HIV-1 RNA less than 100 copiesml continue the ACTG 315 regimen Patients with HIV-1 RNA 100-3000 copiesml may continue the ACTG 315 regimen or initiate a new HAART regimen selected by the local investigator or primary care physician Patients with HIV-1 RNA greater than 3000 copiesml initiate a new HAART regimen selected by the local investigator or primary care physician AS PER AMENDMENT 41000 Changes to regimens must be done in consultation with the study team The team acknowledges that a viable regimen may not be available for a given patient when the plasma HIV RNA level is above 3000 copiesml In this case patients may remain on their failing regimen with evaluation every 8 weeks until a viable regimen becomes available to them All patients are required to maintain a HAART regimen that contains at least 3 drugs 1 of which is a protease inhibitor AS PER AMENDMENT 3501 All patients are required to maintain a HAART regimen that is approved by the protocol chairs Zidovudine ZDV lamivudine 3TC stavudine d4T didanosine ddI delavirdine DLV ritonavir RTV and saquinavir soft gel capsules SQV sgc are provided on-study AS PER AMENDMENT 91900 ZDV 3TC 3TCZDV combination tablet d4T ddI DLV RTV and SQV sgc will be supplied by the protocol for 182 weeks AS PER AMENDMENT 3501 The following antiretroviral medications will be supplied by the protocol for Steps 1 and 2 ZDV 3TC 3TCZDV combination tablet d4T ddI DLV RTV and SQV sgc Therapy is continued for 54 weeks AS PER AMENDMENT 10698 The initial 54-week trial is followed by an additional 2 years of long-term evaluation Also per this amendment protocol therapy is initiated at Week 6 AS PER AMENDMENT 91900 The initial 54-week trial is followed by an additional 25 years of long-term evaluation AS PER AMENDMENT 3501 Step 1 has an initial 54 weeks of treatment followed by 140 weeks of long-term follow-up Step 2 has an additional 36 weeks of long-term follow-up Patients who complete the final visit on Step 2 Week 230 should return to the clinic 4 weeks after receiving the last dose of study-provided medication to complete the final evaluations AS PER AMENDMENT 10698 Patients may co-enroll in an immunology substudy AS PER AMENDMENT 61199 The immunology substudy is being piloted in 3 to 4 volunteers and may not proceed until the feasibility of the pilot project is reviewed
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 |
|---|---|---|---|
| 11336 | REGISTRY | DAIDS ES Registry Number | None |
| Substudy ACTG A5002s | None | None | None |