|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00353327 |
|
Date of registration:
|
17/07/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Study of the Effectiveness of Passive Immunotherapy in HIV-Infected Patients Who Are in Virologic Failure
|
|
Scientific title:
|
Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment. Randomized Study in Two Phases. |
|
Date of first enrolment:
|
October 2006 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Suspended |
|
URL:
|
http://clinicaltrials.gov/show/NCT00353327 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Felipe Garcia, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Clínic Barcelona |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV Infection
|
|
Intervention(s)
|
|
Procedure: Plasma infusion
|
|
Primary Outcome(s)
|
|
Lowering of plasma viral load after a year
|
|
Lowering of plasma viral load after the first plasma infusion
|
|
Secondary Outcome(s)
|
|
Accomplishment
|
|
Dead
|
|
Development of C-events
|
|
Elevation of CD4 T cell count
|
|
HIV RNA mutations conferring resistance to HAART
|
|
Negativation of p24 HIV antigen
|
|
Toxicity
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|