Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011011
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-02-08
Brief Title:
Vaccine ALVAC-HIV vCP1452 Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients With HIV
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 III Pilot Study of Intermittent Withdrawal of Antiretroviral Therapy as an Immunization Strategy and Double-Blinded Immunization With ALVAC-HIV vCP1452 in Subjects With Persistent CD4 Cell Counts Greater Than 400 Cellsmm3 and Plasma HIV-1 RNA Levels Less Than 50 Copiesml
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:
Long-term control of HIV depends on improvement in an individuals immune system The purpose of this study is to see if either stopping anti-HIV drugs for short periods of time andor adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection The study will test whether these treatment approaches are safe The HIV vaccine in this study has been tested in people who did not have HIV infection and improved the way their immune system worked This study will evaluate whether these same immune system changes happen in people with HIV and if such changes do occur assess whether these changes help to improve control of HIV in these patients
Detailed Description:
The best hope for long-term control of HIV infection in an individual likely rests with the resumption of effective HIV-specific immune responses Intermittent antiretroviral therapy ART withdrawal as an attempt to immunize the subject with hisher own active viral quasi-species population represents an alternative approach to traditional immunization strategies This study hopes to determine whether intermittent ART withdrawal serves to stimulate HIV-specific immune responses and control of viral replication This approach will be compared with vaccination with ALVAC-HIV vCP1452 In addition it is conceivable that intermittent ART withdrawal could boost and broaden the prime response to exogenous vaccine that will also be studied
Patients will continue receiving their potent ART not provided by the study and will be randomly assigned to one of four treatment strategies as follows
Arm A ALVAC placebo and potent ART for 92 weeks with a single 12- to 20-week therapy withdrawal period Arm B ALVAC placebo and potent ART for 84 weeks with a 4- to 6-week therapy withdrawal period a 4-week therapy withdrawal period and a 12- to 20-week therapy withdrawal period Arm C ALVAC vCP1452 vaccine and potent ART for 92 weeks with a single 12- to 20-week therapy withdrawal period and Arm D ALVAC vCP1452 vaccine and potent ART for 84 weeks with a 4- to 6-week therapy withdrawal period a 4-week therapy withdrawal period and a 12- to 20-week therapy withdrawal period
Immunizations of placebo or vaccine wil be administered in 3 separate sets of 3 injections per set 9 total and immunization schedules are the same for all patients those undergoing intermittent therapy withdrawal Arms B and D and those who are not Arms A and C
This is a multiple-step study Patients in Arms B and D will receive a 4-week period of potent ART therapy along with the first set of immunizations Step 1 followed by therapy withdrawal for 4 to 6 weeks Step 2 Alternating periods of therapy resumption Step 3 consisting of 16 weeks on potent ART with the second set of vaccine administrations a second therapy withdrawal Step 4 for 4 weeks and another therapy resumption Step 5 consisting of 16 weeks on potent ART with the third set of vaccine administrations will follow Patients in Arms A and C will remain on Step 1 for the first 44 weeks on study
After 44 to 46 weeks on study patients in all arms will have therapy withdrawn for 12 to 20 weeks Step 6 Following completion of Step 6 patients whose viral load are below 10000 copiesml will be encouraged to remain off potent ART Step 7 until completion of the study as long as CD4 T-cell levels remain 50 percent or more of their baseline levels Participants who successfully complete Step 7 will be invited to enter Step 9 a 48-week optional protocol extension Otherwise patients will restart their potent ART regimens Step 8 and receive virologic and CD4 T-cell monitoring until completion of the study
All patients will be monitored at regular clinic visits Viral load and CD4 T-cell counts will be measured at each visit Patients in all arms may participate in substudy A5101s Male Genital Secretions or substudy A5137s Female Genital Secretions and patients in Arms B and D may participate in substudy A5111s Latent Infected T-Cell Clearance
Patients will continue receiving their potent ART not provided by the study and will be randomly assigned to one of four treatment strategies as follows
Arm A ALVAC placebo and potent ART for 92 weeks with a single 12- to 20-week therapy withdrawal period Arm B ALVAC placebo and potent ART for 84 weeks with a 4- to 6-week therapy withdrawal period a 4-week therapy withdrawal period and a 12- to 20-week therapy withdrawal period Arm C ALVAC vCP1452 vaccine and potent ART for 92 weeks with a single 12- to 20-week therapy withdrawal period and Arm D ALVAC vCP1452 vaccine and potent ART for 84 weeks with a 4- to 6-week therapy withdrawal period a 4-week therapy withdrawal period and a 12- to 20-week therapy withdrawal period
Immunizations of placebo or vaccine wil be administered in 3 separate sets of 3 injections per set 9 total and immunization schedules are the same for all patients those undergoing intermittent therapy withdrawal Arms B and D and those who are not Arms A and C
This is a multiple-step study Patients in Arms B and D will receive a 4-week period of potent ART therapy along with the first set of immunizations Step 1 followed by therapy withdrawal for 4 to 6 weeks Step 2 Alternating periods of therapy resumption Step 3 consisting of 16 weeks on potent ART with the second set of vaccine administrations a second therapy withdrawal Step 4 for 4 weeks and another therapy resumption Step 5 consisting of 16 weeks on potent ART with the third set of vaccine administrations will follow Patients in Arms A and C will remain on Step 1 for the first 44 weeks on study
After 44 to 46 weeks on study patients in all arms will have therapy withdrawn for 12 to 20 weeks Step 6 Following completion of Step 6 patients whose viral load are below 10000 copiesml will be encouraged to remain off potent ART Step 7 until completion of the study as long as CD4 T-cell levels remain 50 percent or more of their baseline levels Participants who successfully complete Step 7 will be invited to enter Step 9 a 48-week optional protocol extension Otherwise patients will restart their potent ART regimens Step 8 and receive virologic and CD4 T-cell monitoring until completion of the study
All patients will be monitored at regular clinic visits Viral load and CD4 T-cell counts will be measured at each visit Patients in all arms may participate in substudy A5101s Male Genital Secretions or substudy A5137s Female Genital Secretions and patients in Arms B and D may participate in substudy A5111s Latent Infected T-Cell Clearance
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 |
|---|---|---|---|
| AACTG A5068 | Registry Identifier | DAIDS ES Registry Number | None |
| 10072 | REGISTRY | None | None |
| Substudy AACTG A5101s | None | None | None |
| Substudy AACTG A5111s | None | None | None |
| Substudy AACTG A5137s | None | None | None |
| ACTG A5068 | None | None | None |