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:
Group I: HAART + PIT (n= 15)
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:
Group I: HAART + PIT (n= 15)
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 CD4+/CD8+ 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:
Proportion of patients whose CD4+ T cell count is over 100 cells/mm3 after a year.
Proportion of patients whose p24-antigenemia is below the limits of detection.
Number of mutations conferring resistance to antiretrovirals at the end of the study
compared to the mutations at the beginning.
Type C events.
Death.
Toxicity.
Adherence.