Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080106
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2004-03-23
Brief Title:
Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Double-Blind Randomized Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2013-07
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 vaccines may help the immune systems of HIV infected patients better control the virus The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine While taking anti-HIV medications participants will receive either an HIV vaccine or a placebo Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo
Primary study hypotheses 1The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo 2 the time averaged area under the curve of the log10 HIV-1 RNA copiesml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo
Primary study hypotheses 1The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo 2 the time averaged area under the curve of the log10 HIV-1 RNA copiesml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo
Detailed Description:
Antiretroviral therapy ART has a significant impact on HIV disease however HIV cannot be cured with current drug regimens While the majority of patients initially benefit from ART drug regimens subsequently fail for many patients due to drug resistance poor adherence or toxicity If given while HIV replication is kept in check by ART an HIV vaccine may be able to generate an effective long-term immune response capable of controlling the virus even if ART is discontinued
The MRK Ad5 HIV-1 gag vaccine uses a replication-defective adenovirus vector and has been found safe in clinical trials of both HIV infected and HIV uninfected adults This study will evaluate the ability of immunization with the MRK Ad5 HIV-1 gag vaccine to control HIV replication in individuals undergoing treatment interruption The study will enroll individuals whose HIV replication has been successfully suppressed with ART for at least 2 years
Participants in this study will be randomly assigned to receive either vaccine or placebo Both vaccine and placebo will be injected into the upper arm muscle Participants will take their antiretroviral medications during the first 3 months of the study Injections will be given on Day 1 Week 4 and Week 26 A study nurse will call participants 1 or 2 days after each injection and participants will be asked to fill out a card with any reactions they have to the injections About 3 months after the third injection participants will stop taking their antiretroviral medications for 4 months Participants will have study visits every 2 to 3 weeks while off medication After 4 months participants will have the option of restarting antiretroviral medications or continuing without medication Participants will then have study visits every 2 months for 8 months Study visits will include physical exams and blood collection
All participants will continue to see their primary care provider for HIV treatment and will be restarted on antiretroviral medications if clinically indicated Participants or their primary care provider will be contacted by phone for updates every 6 months for an additional 35 years
The MRK Ad5 HIV-1 gag vaccine uses a replication-defective adenovirus vector and has been found safe in clinical trials of both HIV infected and HIV uninfected adults This study will evaluate the ability of immunization with the MRK Ad5 HIV-1 gag vaccine to control HIV replication in individuals undergoing treatment interruption The study will enroll individuals whose HIV replication has been successfully suppressed with ART for at least 2 years
Participants in this study will be randomly assigned to receive either vaccine or placebo Both vaccine and placebo will be injected into the upper arm muscle Participants will take their antiretroviral medications during the first 3 months of the study Injections will be given on Day 1 Week 4 and Week 26 A study nurse will call participants 1 or 2 days after each injection and participants will be asked to fill out a card with any reactions they have to the injections About 3 months after the third injection participants will stop taking their antiretroviral medications for 4 months Participants will have study visits every 2 to 3 weeks while off medication After 4 months participants will have the option of restarting antiretroviral medications or continuing without medication Participants will then have study visits every 2 months for 8 months Study visits will include physical exams and blood collection
All participants will continue to see their primary care provider for HIV treatment and will be restarted on antiretroviral medications if clinically indicated Participants or their primary care provider will be contacted by phone for updates every 6 months for an additional 35 years
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 A5197 | Registry Identifier | DAIDS ES | None |
| 10014 | REGISTRY | None | None |