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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353327
Recruitment Status : Suspended (low recruitment)
First Posted : July 18, 2006
Last Update Posted : March 31, 2008
Information provided by:
Hospital Clinic of Barcelona

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

Condition or disease Intervention/treatment Phase
HIV Infection Procedure: Plasma infusion Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment. Randomized Study in Two Phases.
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Lowering of plasma viral load after the first plasma infusion
  2. Lowering of plasma viral load after a year

Secondary Outcome Measures :
  1. Elevation of CD4 T cell count
  2. Negativation of p24 HIV antigen
  3. HIV RNA mutations conferring resistance to HAART
  4. Development of C-events
  5. Dead
  6. Toxicity
  7. Accomplishment

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00353327

Hospital Clínic Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Felipe Garcia, MD, PhD Hospital Clinic of Barcelona

Responsible Party: Felipe García, Hospital Clinic Identifier: NCT00353327     History of Changes
Other Study ID Numbers: PIT-01
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008

Keywords provided by Hospital Clinic of Barcelona:
Passive immunotherapy

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases