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

Last updated: March 28, 2008
Sponsor: Hospital Clinic of Barcelona
Overall Status: Suspended

Phase

2/3

Condition

Hiv Infections

Hiv/aids

Aids And Aids Related Infections

Treatment

N/A

Clinical Study ID

NCT00353327
PIT-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HIV-1 infected patients (CDC C category) confirmed by a Western-blot

  • CD4 T cell count under 100/ml form 6 months before the inclusion, and who have neverbeen over 600 CD4 T cells/ml in the last 6 months, even if they have been receivingHAART.

  • The patients have received at least 3 different HAART regimens, and they have failedto respond (define failure: CD4 T cell count under 100/ml and plasma viral load over 20,000 copies/ml).

  • Plasma viral load over 20,000 copies/ml during at least 6 months.

  • Written informed consent

  • 18 years old or older

Exclusion

Exclusion Criteria:

  • Asymptomatic patients who fill the A category of the CDC (1993)

  • Younger than 18 years old

  • Who are not expected to accomplish the treatment or the follow up visits

  • Pregnancy, breast-feeding women, or women who want to get pregnant

  • Denied consent

Study Design

Total Participants: 30
Study Start date:
October 01, 2006
Estimated Completion Date:

Study 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.

Connect with a study center

  • Hospital Clínic Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

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