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

This study has been suspended.

( low recruitment )

First Received on July 17, 2006. Last Updated on March 28, 2008 History of Changes

Sponsor:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00353327

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 II Phase III

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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 Clínic 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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 12, 2012