Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801758
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2021-03-01
Brief Title:
Analytical Treatment Interruption ATI to Assess the Immune Systems Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704HPTN 085 AMP Study
Sponsor:
HIV Vaccine Trials Network
Organization:
HIV Vaccine Trials Network
Study Overview
Official Title:
Antiretroviral Analytical Treatment Interruption ATI to Assess Immunologic and Virologic Responses in Participants Who Received VRC01 or Placebo and Became HIV-infected During HVTN 704HPTN 085
Status:
COMPLETED
Status Verified Date:
2024-08
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 learn whether having the AMP Study antibody called VRC01 in a persons body might help their immune system control HIV better even without HIV medication called antiretroviral therapy or ART if they get HIV This study will evaluate the viral and immune system responses in an Analytical Treatment Interruption ATI in participants who received VRC01 or placebo and got HIV while enrolled in HVTN 704HPTN 085 NCT02716675
Participants in this study will stop taking their HIV medication They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section Detailed Description While they are not taking HIV medication their HIV levels will be tested frequently and their health will be monitored closely This is called an analytical treatment interruption or an ATI An ATI is an experimental procedure that is only used in carefully monitored research
Participants in this study will stop taking their HIV medication They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section Detailed Description While they are not taking HIV medication their HIV levels will be tested frequently and their health will be monitored closely This is called an analytical treatment interruption or an ATI An ATI is an experimental procedure that is only used in carefully monitored research
Detailed Description:
The purpose of this study is to evaluate immunologic and virologic responses in an Analytical Treatment Interruption ATI in participants who received VRC01 or placebo and got HIV while enrolled in the HVTN 704HPTN 085 Antibody-Mediated Prevention AMP Study NCT02716675
ATI begins with the cessation of ART on Schedule 1 Monitoring ATI Participants on Schedule 1 will attend study visits every week for the first 8 weeks and at least every 2 weeks for the next 16 weeks After that participants will attend study visits once a month for the next 6 months if their body is controlling their HIV without ART Participants on Schedule 1 for more than a year will have visits every 3 months
For participants on Schedule 1 Monitoring ATI a confirmed VL 200 copiesmL will trigger transition to Schedule 2 ATI monitoring with viremia Participants on Schedule 2 will attend study visits every week for the first 8 weeks and at least every 2 weeks for the next 28 weeks After that participants will attend study visits once a month for the next 4 months if their body is controlling their HIV without ART Participants on Schedule 2 for more than a year will have visits every 3 months
For participants on Schedule 1 Monitoring ATI any of the following non-virologic criteria will trigger re-initiation of ART and transition to Schedule 3 Follow-up on ART confirmed CD4 T-cell count 350 cellsmm3 any HIV-related syndrome pregnancy or breastfeeding or ART re-initiation requested by participant or if deemed medically necessary by primary HIV provider or clinical research site Investigator of Record Participants on Schedule 3 will attend study visits every 2 weeks for the first 12 weeks once a month for the next 16 weeks and on 2 occasions 3 months apart for the next 24 weeks
For participants on Schedule 2 ATI monitoring with viremia the following virologic criteria will trigger re-initiation of ART and transition to Schedule 3 Follow-up on ART viral load remains 1000 copiesmL for 4 consecutive weeks AND viral load has not dropped 05 log from the previous week Week 0 - Week 24 confirmed viral load 200 copiesmL after Week 24 Or the following non-virologic criteria will trigger re-initiation of ART and transition from Schedule 2 ATI monitoring with viremia to Schedule 3 Follow-up on ART confirmed CD4 T-cell count 350 cellsmm3 any HIV-related syndrome pregnancy or breastfeeding or ART re-initiation requested by participant or if deemed medically necessary by primary HIV provider or clinical research site Investigator of Record
Study duration is potentially indefinite for participants maintaining extreme and extended viral control during ATI Study duration for most participants is expected to be 13-18 months The maximum anticipated duration for any participant is expected to be approximately 2 12 to 3 years
Visits may include medical history review physical exam HIV testing other STI testing blood urine and rectal and oral swab collection blood draws pregnancy testing for participants assigned female sex at birth that can become pregnant HIV transmission risk reduction counseling and interviewsquestionnaires
ATI begins with the cessation of ART on Schedule 1 Monitoring ATI Participants on Schedule 1 will attend study visits every week for the first 8 weeks and at least every 2 weeks for the next 16 weeks After that participants will attend study visits once a month for the next 6 months if their body is controlling their HIV without ART Participants on Schedule 1 for more than a year will have visits every 3 months
For participants on Schedule 1 Monitoring ATI a confirmed VL 200 copiesmL will trigger transition to Schedule 2 ATI monitoring with viremia Participants on Schedule 2 will attend study visits every week for the first 8 weeks and at least every 2 weeks for the next 28 weeks After that participants will attend study visits once a month for the next 4 months if their body is controlling their HIV without ART Participants on Schedule 2 for more than a year will have visits every 3 months
For participants on Schedule 1 Monitoring ATI any of the following non-virologic criteria will trigger re-initiation of ART and transition to Schedule 3 Follow-up on ART confirmed CD4 T-cell count 350 cellsmm3 any HIV-related syndrome pregnancy or breastfeeding or ART re-initiation requested by participant or if deemed medically necessary by primary HIV provider or clinical research site Investigator of Record Participants on Schedule 3 will attend study visits every 2 weeks for the first 12 weeks once a month for the next 16 weeks and on 2 occasions 3 months apart for the next 24 weeks
For participants on Schedule 2 ATI monitoring with viremia the following virologic criteria will trigger re-initiation of ART and transition to Schedule 3 Follow-up on ART viral load remains 1000 copiesmL for 4 consecutive weeks AND viral load has not dropped 05 log from the previous week Week 0 - Week 24 confirmed viral load 200 copiesmL after Week 24 Or the following non-virologic criteria will trigger re-initiation of ART and transition from Schedule 2 ATI monitoring with viremia to Schedule 3 Follow-up on ART confirmed CD4 T-cell count 350 cellsmm3 any HIV-related syndrome pregnancy or breastfeeding or ART re-initiation requested by participant or if deemed medically necessary by primary HIV provider or clinical research site Investigator of Record
Study duration is potentially indefinite for participants maintaining extreme and extended viral control during ATI Study duration for most participants is expected to be 13-18 months The maximum anticipated duration for any participant is expected to be approximately 2 12 to 3 years
Visits may include medical history review physical exam HIV testing other STI testing blood urine and rectal and oral swab collection blood draws pregnancy testing for participants assigned female sex at birth that can become pregnant HIV transmission risk reduction counseling and interviewsquestionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| UM1AI068614 | NIH | None | httpsreporternihgovquickSearchUM1AI068614 |