Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000896
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Controlled Trial to Compare the Efficacy of a Four Drug Antiretroviral Regimen Alone or in Combination With GM-CSF or IL-12 Administered to HIV-1 Infected Subjects as Measured by the Characteristics of Viral Decay
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:
The purpose of this study is to examine how the level of HIV is reduced in the blood when anti-HIV therapy is initiated This study will also evaluate whether adding GM-CSF or IL-12 to the anti-HIV drug regimen will increase the rate that HIV is reduced
The anti-HIV drugs used in this study will include lamivudine 3TC zidovudine ZDV indinavir IDV nevirapine NVP and stavudine d4T All have been used successfully to treat HIV GM-CSF has been used to treat certain blood disorders it will be used as an experimental drug in this study IL-12 interleukin-12 is a protein found naturally in the body that is thought to boost the immune system Although GM-CSF and IL-12 have no direct effect against HIV these drugs may improve the ability of the immune system to fight the virus
The anti-HIV drugs used in this study will include lamivudine 3TC zidovudine ZDV indinavir IDV nevirapine NVP and stavudine d4T All have been used successfully to treat HIV GM-CSF has been used to treat certain blood disorders it will be used as an experimental drug in this study IL-12 interleukin-12 is a protein found naturally in the body that is thought to boost the immune system Although GM-CSF and IL-12 have no direct effect against HIV these drugs may improve the ability of the immune system to fight the virus
Detailed Description:
Potent antiretroviral therapies that suppress HIV replication have permitted mathematical modeling of the dynamics of HIV infection and clearance by measurement of the decay of viral load in plasma When de nova infection is blocked by antiretroviral therapy the viral load decreases exponentially after a short initial lag time shoulder This rapid decline is followed by a slower second-phase decay The intent of this study is to utilize four antiretroviral agents zidovudine lamivudine nevirapine indinavir and very frequent measures of viral load to explore the drug-specific kinetics of the shoulder The decay of long-lived HIV-infected tissue macrophages is thought to be the major determinant of the slow second phase Further the study intends to use immune modulating agents with the potential to increase the turnover of infected macrophages GM-CSF or IL-12 to accelerate the second phase of viral decay
Patients are assigned to Group A 16 patients or to Group B 8 patients Patients in Group A are randomized to 1 of the following 4 initial treatment arms
ARM A Final dose combination FDC Zidovudine ZDVLamivudine 3TC ARM B Nevirapine NVP ARM C Indinavir IDV ARM D FDC ZDV3TC plus NVP plus IDV The initial regimen is maintained over the first 72 hours and blood for viral dynamic evaluations collected while patients are maintained as inpatients Then patients in Arms A B and C initiate FDC ZDV3TC plus NVP plus IDV
Patients assigned to Group B begin the following 4-drug regimen on Day 0
ARM E FDC ZDV3TC plus NVP plus IDV
On Day 7 patients in both Groups A and B are randomized to receive one of the following therapies in addition to their 4-drug regimen
ARM F GM-CSF daily for 2 weeks then thrice weekly MWF ARM G IL-12 twice weekly ARM H No immune modulation Patients may be hospitalized to initiate immune modulation or may be treated as outpatients Immune modulation is discontinued after Week 14 Patients maintain their 4-drug regimen through Week 48 AS PER AMENDMENT 61199 The study duration has been extended to 96 weeks Hepatitis A vaccine inactivated is administered on Weeks 16 and 40 AS PER AMENDMENT 21398 to patients whose baseline hepatitis A serology was negative
Patients are assigned to Group A 16 patients or to Group B 8 patients Patients in Group A are randomized to 1 of the following 4 initial treatment arms
ARM A Final dose combination FDC Zidovudine ZDVLamivudine 3TC ARM B Nevirapine NVP ARM C Indinavir IDV ARM D FDC ZDV3TC plus NVP plus IDV The initial regimen is maintained over the first 72 hours and blood for viral dynamic evaluations collected while patients are maintained as inpatients Then patients in Arms A B and C initiate FDC ZDV3TC plus NVP plus IDV
Patients assigned to Group B begin the following 4-drug regimen on Day 0
ARM E FDC ZDV3TC plus NVP plus IDV
On Day 7 patients in both Groups A and B are randomized to receive one of the following therapies in addition to their 4-drug regimen
ARM F GM-CSF daily for 2 weeks then thrice weekly MWF ARM G IL-12 twice weekly ARM H No immune modulation Patients may be hospitalized to initiate immune modulation or may be treated as outpatients Immune modulation is discontinued after Week 14 Patients maintain their 4-drug regimen through Week 48 AS PER AMENDMENT 61199 The study duration has been extended to 96 weeks Hepatitis A vaccine inactivated is administered on Weeks 16 and 40 AS PER AMENDMENT 21398 to patients whose baseline hepatitis A serology was negative
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 |
|---|---|---|---|
| 11346 | REGISTRY | DAIDS ES Registry Number | None |