Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005915
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2000-06-15
Brief Title:
A Comparison of Two Anti-HIV Treatment Plans
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption STI Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients With Multidrug Resistant MDR Virus
Status:
COMPLETED
Status Verified Date:
2013-09
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 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects
Sometimes the increase in a patients viral load the level of HIV in the blood can be slowed or stopped by taking anti-HIV drugs This does not always happen Sometimes anti-HIV drugs work at first but then stop working When most of the usual anti-HIV drugs no longer seem to work the virus is called multidrug-resistant MDR This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus
Sometimes the increase in a patients viral load the level of HIV in the blood can be slowed or stopped by taking anti-HIV drugs This does not always happen Sometimes anti-HIV drugs work at first but then stop working When most of the usual anti-HIV drugs no longer seem to work the virus is called multidrug-resistant MDR This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus
Detailed Description:
An increasing number of patients are developing multidrug-resistant MDR virus as determined by genotypic antiretroviral resistance testing GART due to treatment failure to suppress viral replication after several rounds of combination antiretroviral therapy The best therapeutic strategy for these patients is uncertain Two strategies currently being used are 1 STI followed by a new antiretroviral regimen and 2 immediate initiation of a new antiretroviral regimen
Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10000 AS PER AMENDMENT 070301 greater than 5000 copiesml Eligible patients attend a baseline visit AS PER AMENDMENT 070301 and a subsequent randomization visit where the qualifying GART results are provided Patients who consent to participate have phenotypic antiretroviral resistance testing PART done on a specimen from the same blood draw that was used for the GART evaluation After PART results are available patients are randomized AS PER AMENDMENT 070301 If the predicted sensitivities are not available for some or all drugs included in the PART the patient may still be randomized to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen The antiretroviral regimens chosen are based on the patients history and both GART and PART results AS PER AMENDMENT 070301 Additional GART and PART may be requested after at least 4 months of antiretroviral treatment Patients have the follow-up data collection done at Months 1-8 and every 4 months thereafter Changes in antiretroviral therapy Grade 4 adverse experiences progression of disease and deaths are reported as they occur Patients are seen for clinical management as often as deemed necessary All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized Some patients may participate in a Point Mutation Substudy AS PER AMENDMENT 070301 Plasma Point Mutation Substudy and PBMC Point Mutation Substudy
Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10000 AS PER AMENDMENT 070301 greater than 5000 copiesml Eligible patients attend a baseline visit AS PER AMENDMENT 070301 and a subsequent randomization visit where the qualifying GART results are provided Patients who consent to participate have phenotypic antiretroviral resistance testing PART done on a specimen from the same blood draw that was used for the GART evaluation After PART results are available patients are randomized AS PER AMENDMENT 070301 If the predicted sensitivities are not available for some or all drugs included in the PART the patient may still be randomized to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen The antiretroviral regimens chosen are based on the patients history and both GART and PART results AS PER AMENDMENT 070301 Additional GART and PART may be requested after at least 4 months of antiretroviral treatment Patients have the follow-up data collection done at Months 1-8 and every 4 months thereafter Changes in antiretroviral therapy Grade 4 adverse experiences progression of disease and deaths are reported as they occur Patients are seen for clinical management as often as deemed necessary All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized Some patients may participate in a Point Mutation Substudy AS PER AMENDMENT 070301 Plasma Point Mutation Substudy and PBMC Point Mutation Substudy
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 |
|---|---|---|---|
| 11619 | REGISTRY | DAIDS ES | None |