NCT00353327

Study of the Effectiveness of Passive Immunotherapy in HIV-Infected Patients Who Are in Virologic Failure

Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment. Randomized Study in Two Phases.

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 cells/ml and a viral load over 20,000 copies/ml.

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 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: 1. Proportion of patients whose CD4+ T cell count is over 100 cells/mm3 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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
PROCEDURE	Plasma infusion

Timeline

• Start date: 2006-10-01
• First posted: 2006-07-18
• Last updated: 2008-03-31

Locations

1 site across 1 country: Spain