Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006509
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2000-11-17
Brief Title:
A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Safety and Immunogenicity Evaluation of a PrimeBoost Vaccine Using ALVAC-HIV vCP 1452 With Recombinant gp160 LAIMN-2 in HIV-Infected Subjects Treated With Antiretroviral Therapy for a Minimum of 2 Years
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if 2 study vaccines ALVAC-HIV vCP1452 and gp160 MNLAI-2 are safe and effective in boosting the bodys attacks on HIV in HIV-positive patients
HIV-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses One way to strengthen these responses may be to have a safe and effective vaccine which will boost immune responses that are specific to HIV
HIV-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses One way to strengthen these responses may be to have a safe and effective vaccine which will boost immune responses that are specific to HIV
Detailed Description:
HIV-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of HIV-specific immune responses In these patients a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity The hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested
Patients continue antiretroviral medications throughout the course of this study All patients receive intramuscular injections of ALVAC-HIV vCP 1452 and recombinant soluble gp160 MNLAI-2 on Days 0 30 90 and 180 Patients are monitored for safety 30 minutes after each immunization and by telephone contact within 72 hours of each vaccination In addition each patient records adverse events in a diary Patients have regular physical exams pregnancy tests and blood drawn for virologic and immunologic assessments The induction of HIV-specific responses will be measured
Patients continue antiretroviral medications throughout the course of this study All patients receive intramuscular injections of ALVAC-HIV vCP 1452 and recombinant soluble gp160 MNLAI-2 on Days 0 30 90 and 180 Patients are monitored for safety 30 minutes after each immunization and by telephone contact within 72 hours of each vaccination In addition each patient records adverse events in a diary Patients have regular physical exams pregnancy tests and blood drawn for virologic and immunologic assessments The induction of HIV-specific responses will be measured
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 |
|---|---|---|---|
| AIEDRP AI-04-006 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01AI041534-01 |
| GCRC M01-RR00102 | None | None | None |
| U01AI041534-01 | NIH | None | None |
| PMCADARC-001 | None | None | None |