Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353327
Status:
SUSPENDED
Last Update Posted:
2008-03-31
First Post:
2006-07-17
Brief Title:
Study of the Effectiveness of Passive Immunotherapy in HIV-Infected Patients Who Are in Virologic Failure
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment Randomized Study in Two Phases
Status:
SUSPENDED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the effect of passive immunotherapy PIT over the HIV-viral load and the CD4 T-cell counts in patients who have failed to respond to three different Highly-Active Antiretroviral Therapy HAART and who have at the moment less than 100 CD4-T cellsml and a viral load over 20000 copiesml
Detailed Description:
Double blind comparative randomized study with placebo in two phases
Phase I I A pilot study to asses the virologic efficacy in 30 patients will be done They will be under the same HAART regimen and they will be randomized to receive
1 Group I HAART PIT n 15
2 Group II HAART placebo non-hyperimmune plasma n 15
Passive immunotherapy will consist in 500 cc of inactivated plasma with methylene-blue standard inactivation method from asymptomatic patients in early phases of the infection A transfusion will be done and a complete blood test including viral load and CD4-T cell counts will be done at days 3 7 14 21 and 28 The non-hyperimmune plasma Group II will be inactivated by the same method
A second dose of hyperimmune plasma and placebo Group I and Group II respectively will be administered at 1 month from the beginning of the trial
A complete blood test including viral load and CD4-T cell counts will be done at month 2 3 and 4
Phase II 30 patients under the same HAART regimen will be randomized to receive
1 Group I HAART PIT n 15
2 Group II HAART placebo non-hyperimmune plasma n 15
Passive immunotherapy will consist in 500 cc of inactivated plasma with methylene-blue standard inactivation method from asymptomatic patients in early phases of the infection guided by the neutralization capacity of the plasma donors over the virus receptor A transfusion will be done and a complete blood test including viral load and CD4-T cell counts will be done at days 3 7 14 21 and 28 The non-hyperimmune plasma Group II will be inactivated by the same method
A second dose of hyperimmune plasma and placebo Group I and Group II respectively will be administered at 1 month from the beginning of the phase II
The patients will remain under HAART the next year A complete clinical examination and a blood test that includes hemogram and biochemical parameters renal and hepatic function and viral load will be done each month Every three months a CD4CD8 T cell count will be done and it will be obtained plasma and serum from each patient
Additionally a genotype and a virtual phenotype of the HIV will be obtained at the beginning and at the end of the study
Study end-points
-Main end-point Phase I proportion of patients who reduce their plasma viral load or 1 log after two infusions of hyperimmune plasma
Phase II proportion of patients who reduce their plasma viral load or 1 log after a year
- Secondary end-points
1 Proportion of patients whose CD4 T cell count is over 100 cellsmm3 after a year
2 Proportion of patients whose p24-antigenemia is below the limits of detection
3 Number of mutations conferring resistance to antiretrovirals at the end of the study compared to the mutations at the beginning
4 Type C events
5 Death
6 Toxicity
7 Adherence
Phase I I A pilot study to asses the virologic efficacy in 30 patients will be done They will be under the same HAART regimen and they will be randomized to receive
1 Group I HAART PIT n 15
2 Group II HAART placebo non-hyperimmune plasma n 15
Passive immunotherapy will consist in 500 cc of inactivated plasma with methylene-blue standard inactivation method from asymptomatic patients in early phases of the infection A transfusion will be done and a complete blood test including viral load and CD4-T cell counts will be done at days 3 7 14 21 and 28 The non-hyperimmune plasma Group II will be inactivated by the same method
A second dose of hyperimmune plasma and placebo Group I and Group II respectively will be administered at 1 month from the beginning of the trial
A complete blood test including viral load and CD4-T cell counts will be done at month 2 3 and 4
Phase II 30 patients under the same HAART regimen will be randomized to receive
1 Group I HAART PIT n 15
2 Group II HAART placebo non-hyperimmune plasma n 15
Passive immunotherapy will consist in 500 cc of inactivated plasma with methylene-blue standard inactivation method from asymptomatic patients in early phases of the infection guided by the neutralization capacity of the plasma donors over the virus receptor A transfusion will be done and a complete blood test including viral load and CD4-T cell counts will be done at days 3 7 14 21 and 28 The non-hyperimmune plasma Group II will be inactivated by the same method
A second dose of hyperimmune plasma and placebo Group I and Group II respectively will be administered at 1 month from the beginning of the phase II
The patients will remain under HAART the next year A complete clinical examination and a blood test that includes hemogram and biochemical parameters renal and hepatic function and viral load will be done each month Every three months a CD4CD8 T cell count will be done and it will be obtained plasma and serum from each patient
Additionally a genotype and a virtual phenotype of the HIV will be obtained at the beginning and at the end of the study
Study end-points
-Main end-point Phase I proportion of patients who reduce their plasma viral load or 1 log after two infusions of hyperimmune plasma
Phase II proportion of patients who reduce their plasma viral load or 1 log after a year
- Secondary end-points
1 Proportion of patients whose CD4 T cell count is over 100 cellsmm3 after a year
2 Proportion of patients whose p24-antigenemia is below the limits of detection
3 Number of mutations conferring resistance to antiretrovirals at the end of the study compared to the mutations at the beginning
4 Type C events
5 Death
6 Toxicity
7 Adherence
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