Status:
SUSPENDED
Study of the Effectiveness of Passive Immunotherapy in HIV-Infected Patients Who Are in Virologic Failure
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 (HA...
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,...
Eligibility Criteria
Inclusion
- 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 never been over 600 CD4 T cells/ml in the last 6 months, even if they have been receiving HAART.
- The patients have received at least 3 different HAART regimens, and they have failed to 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00353327
Start Date
October 1 2006
Last Update
March 31 2008
Active Locations (1)
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1
Hospital Clínic Barcelona
Barcelona, Spain, 08036