Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107549
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-04-05
Brief Title:
Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Open-Label Study to Evaluate the Safety and Tolerability of Recombinant HIV-1 Vaccines in HIV-1 Infected Young Adults With Control of HIV-1 Replication and on Stable Highly Active Antiretroviral Therapy HAART
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 the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy
Detailed Description:
By helping to control viral replication HAART has dramatically improved the prognosis for HIV infected individuals However because of extensive side effects some of which may be acute and life-threatening many patients find it difficult to tolerate a HAART regimen HAART-associated long-term morbidity or mortality contribute to this difficulty Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or interrupt treatment avoiding the side effects associated with antiretroviral exposure This study will evaluate the safety of two injections of two recombinant therapeutic vaccines in HIV infected young adults who are currently on stable HAART
This study will last 72 weeks All participants will receive two rMVA vaccines envgag and tatrevnef-RT at study entry and at Week 4 and two rFPV vaccines envgag and tatrevnef-RT at Weeks 8 and 24 Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization There will be 16 study visits over 72 weeks A physical exam blood collection and administration of an adherence module will occur at most visits An electrocardiogram ECG will occur at study entry and Weeks 2 and 10 Urine collection will occur at study entry and Weeks 4 8 and 24
This study will last 72 weeks All participants will receive two rMVA vaccines envgag and tatrevnef-RT at study entry and at Week 4 and two rFPV vaccines envgag and tatrevnef-RT at Weeks 8 and 24 Safety will be assessed immediately after each immunization and at 1 hour and 48 hours postimmunization There will be 16 study visits over 72 weeks A physical exam blood collection and administration of an adherence module will occur at most visits An electrocardiogram ECG will occur at study entry and Weeks 2 and 10 Urine collection will occur at study entry and Weeks 4 8 and 24
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 |
|---|---|---|---|
| 10051 | REGISTRY | None | None |
| PACTG P1059 | Registry Identifier | DAIDS ES Registry Number | None |