Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480792
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2007-05-30
Brief Title:
Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV Infected Patients
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Open-label Randomized and Multicentric Phase III Clinical Trial Comparing Three Strategies of Vaccination Against the Virus of Hepatitis B in HIV-1-infected Patients With CD4-positive T-lymphocytes Counts Above 200 permm3 ANRS HB 03 VIHVAC-B
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:
VIHVAC-B
Brief Summary:
In HIV infected patients individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer
However the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients and in case of response its longevity has to be followed up carefully This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B in HIV-infected patients with lymphocytes T CD4 level above 200 permm3
However the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients and in case of response its longevity has to be followed up carefully This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B in HIV-infected patients with lymphocytes T CD4 level above 200 permm3
Detailed Description:
Comparison of 3 vaccination strategy against Hepatitis B in patients with HIV infection T CD4 above 200 per mm3
Intervention
1 Arm A GenHevac-B 20 microgramme Intramuscular use at M0 M1 M6
2 Arm B GenHevac-B 40 microgramme Intramuscular use at M0 M1 M2 M6
3 Arm C GenHevac-B 4 microgramme Intradermal use at M0 M1 M2 M6
Intervention
1 Arm A GenHevac-B 20 microgramme Intramuscular use at M0 M1 M6
2 Arm B GenHevac-B 40 microgramme Intramuscular use at M0 M1 M2 M6
3 Arm C GenHevac-B 4 microgramme Intradermal use at M0 M1 M2 M6
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 |
|---|---|---|---|
| ANRS HB 03 VIHVAC-B | None | None | None |