Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183261
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-09-13
Brief Title:
Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase II Study of Therapeutic Immunization and Treatment Interruption Among Subjects Who Began Potent Antiretroviral Therapy Within 30 Days of Diagnosis of Acute or Recent HIV Infection
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 the HIV vaccine MRKAd5 HIV-1 gagpolnef followed by treatment interruption can increase immune system function in adults with acute or recent HIV infection who have started taking anti-HIV drugs
Detailed Description:
While the advent of highly active antiretroviral therapy HAART has contributed to the increasing control of HIV infection and viral replication ultimate control of HIV infection will require the development of effective HIV-specific immunity in HIV infected individuals Therapeutic vaccination within the earliest weeks following acute or recent HIV infection may increase the immune systems response to HIV This study will determine whether MRKAd5 HIV-1 gagpolnef vaccine followed by treatment interruption can maintain viral suppression in patients with acute or recent HIV infection
The interventional part of the study will last 102 weeks Participants will be randomly assigned to receive either MRKAd5 HIV-1 gagpolnef or placebo vaccine at baseline and Weeks 4 and 26 Participants must remain on HAART from study entry until Week 38 Participants whose HIV viral load rebounds two times or more above 500 copiesml by Weeks 39 to 41 will not enter Step 2 of the study Participants whose viral load drops to 500 copiesml or less by Weeks 39 to 41 will enter Step 2 where they will discontinue HAART for 24 weeks Participants in Step 2 will have plasma HIV viral loads measured every 2 weeks for the first 4 weeks and weekly for the next 3 weeks Study participants will continue in Step 2 until they experience virologic and immunologic failure or they need to restart HAART for another reason they will then enter Step 3 where they will reinitiate HAART Step 3 participants will continue on HAART until Week 102 A long-term safety follow-up period will occur from Weeks 103 to 240
Timing of the study visits will be determined by which steps a participant enters A physical exam and blood and urine collection will occur at most study visits throughout the study until Week 102 Follow-up phone calls to study participants will occur every 6 months from Week 102 until Week 240 to collect long-term safety data including clinical status CD4 count and medication history During the long-term safety follow-up participants will also have study visits every 6 months Visits will include medical and medication history
The interventional part of the study will last 102 weeks Participants will be randomly assigned to receive either MRKAd5 HIV-1 gagpolnef or placebo vaccine at baseline and Weeks 4 and 26 Participants must remain on HAART from study entry until Week 38 Participants whose HIV viral load rebounds two times or more above 500 copiesml by Weeks 39 to 41 will not enter Step 2 of the study Participants whose viral load drops to 500 copiesml or less by Weeks 39 to 41 will enter Step 2 where they will discontinue HAART for 24 weeks Participants in Step 2 will have plasma HIV viral loads measured every 2 weeks for the first 4 weeks and weekly for the next 3 weeks Study participants will continue in Step 2 until they experience virologic and immunologic failure or they need to restart HAART for another reason they will then enter Step 3 where they will reinitiate HAART Step 3 participants will continue on HAART until Week 102 A long-term safety follow-up period will occur from Weeks 103 to 240
Timing of the study visits will be determined by which steps a participant enters A physical exam and blood and urine collection will occur at most study visits throughout the study until Week 102 Follow-up phone calls to study participants will occur every 6 months from Week 102 until Week 240 to collect long-term safety data including clinical status CD4 count and medication history During the long-term safety follow-up participants will also have study visits every 6 months Visits will include medical and medication history
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 |
|---|---|---|---|
| AIN504-A5218 | Registry Identifier | DAIDS ES | None |
| 10025 | REGISTRY | None | None |
| AIN504ACTG A5218 | None | None | None |