Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337181
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2006-06-14
Brief Title:
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Extended Evaluation of the Virologic Immunologic and Clinical Course of Volunteers Who Become HIV-1 Infected During Participation in a Phase III Vaccine Trial of ALVAC-HIV and AIDSVAX BE
Status:
COMPLETED
Status Verified Date:
2018-08
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:
This protocol will study the clinical course of HIV-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and AIDSVAX BE prior to HIV-1 infection in reference to study NCT00223080 RV144 The study will assess whether those who received the experimental vaccine combination have a slower progression of HIV disease compared to those who received the placebo injection
Detailed Description:
Prospective cohort study of the clinical course of HIV-1 infection occurring after candidate HIV-1 vaccination breakthrough infection with ALVAC-HIV vcP1521 and AIDSVAX BE in reference to study NCT00223080 RV144 This study will enroll volunteers who become HIV-infected during the course of follow up in a phase III preventive HIV vaccine trial conducted in Rayong and Chon Buri Thailand Volunteers will be enrolled in this protocol to provide additional long-term follow up to establish whether differences in viral load after infection comparing vaccine to placebo are associated with altered disease outcomes as well as provide more detailed immunologic and virologic assessment of these volunteers
After enrollment in RV152 follow-up visits were scheduled at 0 1 3 and 6 months and every 3 months thereafter After month 12 CD4 T cell counts and viral load were obtained at 6-month intervals until the CD4 T cell count declined to 350ul or highly-active antiretroviral therapy HAART was initiated at which time CD4 T cell counts and viral load were obtained every 3 months Peripartum antiretroviral drugs given for prevention of mother-to-child-transmission was not considered a study endpoint however HAART initiated during pregnancy and continued post-partum was counted After a single CD4 T-cell count 350ul a second sample was requested about 2 weeks later and if the confirmatory measurement was 350ul a study endpoint was not registered and the volunteer resumed a normal visit schedule A single genital fluid collection for viral load was obtained at the first RV152 visit Clinical and laboratory data from RV144 including CD4 T-cell and HIV-1 plasma viral load measurements were linked to RV152 to inform primary and secondary protocol analyses as well as volunteer care and treatment
After enrollment in RV152 follow-up visits were scheduled at 0 1 3 and 6 months and every 3 months thereafter After month 12 CD4 T cell counts and viral load were obtained at 6-month intervals until the CD4 T cell count declined to 350ul or highly-active antiretroviral therapy HAART was initiated at which time CD4 T cell counts and viral load were obtained every 3 months Peripartum antiretroviral drugs given for prevention of mother-to-child-transmission was not considered a study endpoint however HAART initiated during pregnancy and continued post-partum was counted After a single CD4 T-cell count 350ul a second sample was requested about 2 weeks later and if the confirmatory measurement was 350ul a study endpoint was not registered and the volunteer resumed a normal visit schedule A single genital fluid collection for viral load was obtained at the first RV152 visit Clinical and laboratory data from RV144 including CD4 T-cell and HIV-1 plasma viral load measurements were linked to RV152 to inform primary and secondary protocol analyses as well as volunteer care and treatment
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 |
|---|---|---|---|
| RV152 | OTHER | WRAIR | None |