Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001132
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2000-01-17
Brief Title:
Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2003-06
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 see if adding 1 drug to an anti-HIV drug combination early in treatment against HIV can lower the viral load amount of HIV in the blood to a level so low that it cannot be measured undetectable The drug that will be added to a treatment is abacavir ABC
Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads for example viral loads below 50 copiesml However some patients taking only 3 drugs are not able to achieve a viral load this low Doctors hope that by adding the drug ABC to a current treatment a viral load below 50 copiesml can be achieved Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug treatment intensification if the treatment is not working as well as hoped
Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads for example viral loads below 50 copiesml However some patients taking only 3 drugs are not able to achieve a viral load this low Doctors hope that by adding the drug ABC to a current treatment a viral load below 50 copiesml can be achieved Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug treatment intensification if the treatment is not working as well as hoped
Detailed Description:
Combination antiretroviral therapy can offer patients potent suppression of HIV replication and improved immunologic functioning However despite aggressive antiretroviral regimens currently in use only about 50 to 60 percent of patients attain plasma viral loads below 50 copiesml after 24 weeks Initiating treatment with a 4-drug regimen may increase this percentage but this may also contribute to patient non-adherence drug-related toxicities potential cross-resistance to drugs used in future regimens and high financial costs Another strategy is early intensification adding a single drug to an existing regimen in patients who are at risk for attaining incomplete viral suppression after 24 weeks of therapy ABC may produce a significant antiviral effect when used as an intensification agent in patients on a stable antiretroviral regimen The results of this study will offer insight into the potential benefits of early treatment intensification
Patients entering this study will have initiated potent antiretroviral therapy Between 60 and 90 days AS PER AMENDMENT 1901 60 and 104 days after beginning their background regimen patients are randomized to add either ABC Arm A or a matching placebo Arm B for 12 weeks Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36 Patients discontinue treatment if virologic failure occurs at any time Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36 depending on when discontinuation occurred Patients who discontinue treatment at or after Week 12 due to virologic failure are offered open-label ABC for the remainder of the study through Week 36 Blood samples are collected at Weeks 4 8 12 20 28 and 36 Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure Baseline genotype presence or absence of PR and RT resistance mutations and number of resistance mutations is correlated to treatment outcome Samples from the time of failure are analyzed for the accumulation of additional resistance mutations AS PER AMENDMENT 5500 Patients and their primary care physicians will be unblinded to the patients treatment after the study is completed at Week 36 or if virologic failure occurs at or after Week 12 AS PER AMENDMENT 1901 or if ABC hypersensitivity is suspected
Patients entering this study will have initiated potent antiretroviral therapy Between 60 and 90 days AS PER AMENDMENT 1901 60 and 104 days after beginning their background regimen patients are randomized to add either ABC Arm A or a matching placebo Arm B for 12 weeks Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36 Patients discontinue treatment if virologic failure occurs at any time Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36 depending on when discontinuation occurred Patients who discontinue treatment at or after Week 12 due to virologic failure are offered open-label ABC for the remainder of the study through Week 36 Blood samples are collected at Weeks 4 8 12 20 28 and 36 Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure Baseline genotype presence or absence of PR and RT resistance mutations and number of resistance mutations is correlated to treatment outcome Samples from the time of failure are analyzed for the accumulation of additional resistance mutations AS PER AMENDMENT 5500 Patients and their primary care physicians will be unblinded to the patients treatment after the study is completed at Week 36 or if virologic failure occurs at or after Week 12 AS PER AMENDMENT 1901 or if ABC hypersensitivity is suspected
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 |
|---|---|---|---|
| AACTG A5064 | None | None | None |