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

NCT00353327 | Suspended Phase 2

• 1 other identifier: PIT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

HIV; Passive immunotherapy

Outcome Measures

Primary Outcomes (2)

• Lowering of plasma viral load after the first plasma infusion

• Lowering of plasma viral load after a year

Secondary Outcomes (7)

• Elevation of CD4 T cell count

• Negativation of p24 HIV antigen

• HIV RNA mutations conferring resistance to HAART

• Development of C-events

• Dead

Interventions

Plasma infusion PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Felipe Garcia, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 17, 2006
• First Posted: July 18, 2006
• Study Start: October 1, 2006
• Last Updated: March 31, 2008

Record last verified: 2008-03

Locations

ES (1)