Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050063
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-11-20
Brief Title:
Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Rollover Study of A5058s A Phase II Trial to Evaluate the Ability of Vaccine-Induced Helper and CTL Responses to Control Viremia in the Absence of 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:
The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued
Detailed Description:
This study is a rollover study for patients who participated in A5058s Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies In A5058s patients received a series of therapeutic vaccinations to elicit HIV-specific immune responses This study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy ART
Upon study entry patients will discontinue ART During the first 6 weeks of the study viral load will be monitored weekly and CD4 T-cell counts will be monitored every other week Viral load and CD4 T-cell counts will be measured every other week from Week 6 through Week 24 then monthly until patients restart ART or until Week 48 Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks
Upon study entry patients will discontinue ART During the first 6 weeks of the study viral load will be monitored weekly and CD4 T-cell counts will be monitored every other week Viral load and CD4 T-cell counts will be measured every other week from Week 6 through Week 24 then monthly until patients restart ART or until Week 48 Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks
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 A5172 | Registry Identifier | DAIDS ES Registry Number | None |
| 10184 | REGISTRY | None | None |