Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102934
Status:
UNKNOWN
Last Update Posted:
2008-09-17
First Post:
2005-02-04
Brief Title:
Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Treatment Intensification in HIV-1 Patients With Multi-Drug Resistant Virus
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Drug resistance may develop in HIV infected patients who take anti-HIV drugs but most patients do well if they continue taking them The purpose of this study is to test the effectiveness of a short intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs
Detailed Description:
While an HIV infected patient is taking highly active antiretroviral therapy HAART drug-resistant HIV may emerge however it has been observed that HIV viral loads while on HAART are usually lower than baseline levels Expansion of the T cell population during early HAART may explain this phenomenon It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus This study will determine if a 6-month HAART regimen intensified by enfuvirtide T-20 is effective in eliciting a stronger immune response against drug-resistant virus
This study will last 48 weeks All participants will receive T-20 as part of a HAART intensification regimen HAART other than T-20 will not be provided by the study There will be 17 study visits Prior to beginning treatment intensification participants will have weekly study visits for three weeks Once treatment intensification has started participants will be followed weekly for four weeks then weekly for four weeks after treatment intensification then monthly thereafter Blood collection will occur at each visit
This study will last 48 weeks All participants will receive T-20 as part of a HAART intensification regimen HAART other than T-20 will not be provided by the study There will be 17 study visits Prior to beginning treatment intensification participants will have weekly study visits for three weeks Once treatment intensification has started participants will be followed weekly for four weeks then weekly for four weeks after treatment intensification then monthly thereafter Blood collection will occur at each visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol 834 | None | None | None |
| 5R21AI055273-02 | NIH | None | httpsreporternihgovquickSearch5R21AI055273-02 |