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

This study has suspended participant recruitment.
(low recruitment)
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00353327
First received: July 17, 2006
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
HIV Infection
Procedure: Plasma infusion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Lowering of plasma viral load after the first plasma infusion
  • Lowering of plasma viral load after a year

Secondary Outcome Measures:
  • Elevation of CD4 T cell count
  • Negativation of p24 HIV antigen
  • HIV RNA mutations conferring resistance to HAART
  • Development of C-events
  • Dead
  • Toxicity
  • Accomplishment

Estimated Enrollment: 30
Study Start Date: October 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353327

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

No publications provided

Responsible Party: Felipe García, Hospital Clinic
ClinicalTrials.gov Identifier: NCT00353327     History of Changes
Other Study ID Numbers: PIT-01
Study First Received: July 17, 2006
Last Updated: March 28, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Clinic of Barcelona:
HIV
Passive immunotherapy

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

ClinicalTrials.gov processed this record on October 21, 2014