Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051831
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2003-01-16
Brief Title:
Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults
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 to Measure the Clearance of Replication-Competent HIV-1 in Resting Memory CD4 Cells in HIV-1-Infected Subjects Who Receive Enfuvirtide Plus Oral Combination Antiretroviral Therapy
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:
HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells Enfuvirtide also known as T-20 is a type of anti-HIV drug called a fusion inhibitor The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV
Detailed Description:
While current HIV treatment with combination antiretroviral therapy ART has reduced morbidity and mortality it does not eradicate or cure HIV infection A possible explanation for this failure is the persistence of virus in long-lived reservoirs Resting memory CD4 cells have been proposed as providing a cellular reservoir Most patients who initiate ART during chronic HIV-1 infection do not experience a detectable reduction in HIV in the latent reservoir this may be due to low levels of ongoing viral replication that maintains the resting CD4 cell reservoir Increasing the potency of therapy by inhibiting new viral targets may result in a decrease in the number of latently infected cells and clearance of the latent reservoir Addition of the fusion inhibitor T-20 to ART including reverse transcriptase inhibitors and protease inhibitors PIs may help achieve this goal This study will evaluate whether treatment naive chronically infected HIV patients treated with T-20 plus emtricitabine FTC ritonavir RTV saquinavir SQV and tenofovir disoproxil fumarate TDF have a measurable decline in the latently infected CD4 cell reservoir Patients and their physicians may choose different PIs than RTV and SQV but they will not be provided by the study
Patients in this study will receive injections of T-20 twice daily in addition to oral FTC and TDF once daily and oral RTV and SQV twice daily At Week 24 patients will have their latent cell reservoir sampled Patients whose HIV viral loads are less than 50 copiesml at or after Week 24 but prior to Week 48 will continue the treatment regimen through the end of the study their latent cell reservoirs will be tested at Weeks 48 72 and 96 Patients whose viral loads are between 50 copiesml and 200 copiesml will continue the treatment regimen and latent cell sampling but their regimens may be intensified as determined by the study team Patients whose viral loads are 200 copiesml or greater after Week 24 may continue their study regimens but will no longer contribute latent cell samples
This study will last 96 weeks During the first 4 months of the study patients will have 7 study visits after that study visits will be every 8 weeks until the end of the study Medical history clinical assessments and blood collection will occur at every study visit Pill and ENF vial counts will be assessed and patients will be asked to complete a medication adherence questionnaire at selected study visits
Patients in this study will receive injections of T-20 twice daily in addition to oral FTC and TDF once daily and oral RTV and SQV twice daily At Week 24 patients will have their latent cell reservoir sampled Patients whose HIV viral loads are less than 50 copiesml at or after Week 24 but prior to Week 48 will continue the treatment regimen through the end of the study their latent cell reservoirs will be tested at Weeks 48 72 and 96 Patients whose viral loads are between 50 copiesml and 200 copiesml will continue the treatment regimen and latent cell sampling but their regimens may be intensified as determined by the study team Patients whose viral loads are 200 copiesml or greater after Week 24 may continue their study regimens but will no longer contribute latent cell samples
This study will last 96 weeks During the first 4 months of the study patients will have 7 study visits after that study visits will be every 8 weeks until the end of the study Medical history clinical assessments and blood collection will occur at every study visit Pill and ENF vial counts will be assessed and patients will be asked to complete a medication adherence questionnaire at selected study visits
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 |
|---|---|---|---|
| ACTG A5173 | Registry Identifier | DAIDS ES | None |
| 10006 | REGISTRY | None | None |