Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006490
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2000-11-08
Brief Title:
A Comparison of Two Tests for Anti-HIV Drug Resistance
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HIV-1 Resistance Testing During Antiretroviral Failure Comparison of Sequencing Versus Phenotyping
Status:
COMPLETED
Status Verified Date:
2004-07
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 compare 2 different types of tests of the HIV virus to see which specific anti-HIV drugs would work the best
Drug resistance is a major reason for therapy failure in HIV patients Two types of tests can detect resistance to drugs 1 genotyping sequencing which looks at the DNA sequence of a virus to see whether it has developed any genetic resistance 2 phenotyping which looks at the ability of different drugs to suppress virus growth in the laboratory Genotyping and phenotyping can help doctors give patients the most effective drug therapy
Drug resistance is a major reason for therapy failure in HIV patients Two types of tests can detect resistance to drugs 1 genotyping sequencing which looks at the DNA sequence of a virus to see whether it has developed any genetic resistance 2 phenotyping which looks at the ability of different drugs to suppress virus growth in the laboratory Genotyping and phenotyping can help doctors give patients the most effective drug therapy
Detailed Description:
The emergence of drug resistance is a major factor contributing to the failure of antiretroviral therapy in HIV-infected patients Drug resistance can be detected by genotypic or phenotypic assays both having distinct advantages and disadvantages Results from genotypic and phenotypic testing are helpful in excluding from the subsequent regimen drugs to which the resistance is identified and both tests predict virologic response to salvage therapy in patients who have failed a previous regimen Resistance testing is likely to be beneficial as an aid in selecting a salvage regimen
At entry patients are randomized to Arm A sequencing or Arm B phenotyping and have a resistance test drawn while still receiving the current regimen even though regimen failure is suspected The test results are available between Weeks 1 and 4 inclusive There are weekly visits for the first 4 weeks after entry to monitor viral load and maintenance of the current failing prestudy regimen If virologic failure is confirmed a new regimen is chosen and prescribed at the first visit after resistance test results are available AS PER AMENDMENT 12600 If the resistance assay fails to yield results another regimen is chosen and prescribed based on the patients medical and medication history If virologic failure is not confirmed the current drug regimen is not changed Otherwise on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter through Week 48 AS PER AMENDMENT 12600 on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter Medical resource use is assessed at baseline and then every 8 weeks through Week 48 Quality of life is assessed at baseline and then every 16 weeks through Week 48
At entry patients are randomized to Arm A sequencing or Arm B phenotyping and have a resistance test drawn while still receiving the current regimen even though regimen failure is suspected The test results are available between Weeks 1 and 4 inclusive There are weekly visits for the first 4 weeks after entry to monitor viral load and maintenance of the current failing prestudy regimen If virologic failure is confirmed a new regimen is chosen and prescribed at the first visit after resistance test results are available AS PER AMENDMENT 12600 If the resistance assay fails to yield results another regimen is chosen and prescribed based on the patients medical and medication history If virologic failure is not confirmed the current drug regimen is not changed Otherwise on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter through Week 48 AS PER AMENDMENT 12600 on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter Medical resource use is assessed at baseline and then every 8 weeks through Week 48 Quality of life is assessed at baseline and then every 16 weeks through Week 48
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 A5076 | None | None | None |