- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353327
Study of the Effectiveness of Passive Immunotherapy in HIV-Infected Patients Who Are in Virologic Failure
Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment. Randomized Study in Two Phases.
Study Overview
Detailed Description
Double blind comparative randomized study with placebo in two phases:
Phase I: I: A pilot study to asses the virologic efficacy in 30 patients will be done. They will be under the same HAART regimen, and they will be randomized to receive:
- Group I: HAART + PIT (n= 15)
- Group II: HAART + placebo (non-hyperimmune plasma) (n= 15)
Passive immunotherapy will consist in 500 cc of inactivated plasma with methylene-blue (standard inactivation method) from asymptomatic patients in early phases of the infection. A transfusion will be done, and a complete blood test including viral load and CD4+-T cell counts will be done at days 3, 7, 14, 21 and 28. The non-hyperimmune plasma (Group II) will be inactivated by the same method.
A second dose of hyperimmune plasma and placebo (Group I and Group II respectively) will be administered at +1 month from the beginning of the trial.
A complete blood test including viral load and CD4+-T cell counts will be done at month +2, +3 and +4.
Phase II: 30 patients under the same HAART regimen will be randomized to receive:
- Group I: HAART + PIT (n= 15)
- Group II: HAART + placebo (non-hyperimmune plasma) (n= 15)
Passive immunotherapy will consist in 500 cc of inactivated plasma with methylene-blue (standard inactivation method) from asymptomatic patients in early phases of the infection, guided by the neutralization capacity of the plasma donors over the virus' receptor . A transfusion will be done, and a complete blood test including viral load and CD4+-T cell counts will be done at days 3, 7, 14, 21 and 28. The non-hyperimmune plasma (Group II) will be inactivated by the same method.
A second dose of hyperimmune plasma and placebo (Group I and Group II respectively) will be administered at +1 month from the beginning of the phase II.
The patients will remain under HAART the next year. A complete clinical examination, and a blood test that includes hemogram and biochemical parameters (renal and hepatic function), and viral load will be done each month. Every three months, a CD4+/CD8+ T cell count will be done, and it will be obtained plasma and serum from each patient.
Additionally, a genotype and a virtual phenotype of the HIV will be obtained at the beginning and at the end of the study.
Study end-points:
-Main end-point: Phase I: proportion of patients who reduce their plasma viral load > or = 1 log after two infusions of hyperimmune plasma.
Phase II: proportion of patients who reduce their plasma viral load > or = 1 log after a year.
- Secondary end-points:
- Proportion of patients whose CD4+ T cell count is over 100 cells/mm3 after a year.
- Proportion of patients whose p24-antigenemia is below the limits of detection.
- Number of mutations conferring resistance to antiretrovirals at the end of the study compared to the mutations at the beginning.
- Type C events.
- Death.
- Toxicity.
- Adherence.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic Barcelona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Lowering of plasma viral load after the first plasma infusion
|
Lowering of plasma viral load after a year
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Elevation of CD4 T cell count
|
Negativation of p24 HIV antigen
|
HIV RNA mutations conferring resistance to HAART
|
Development of C-events
|
Dead
|
Accomplishment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Felipe Garcia, MD, PhD, Hospital Clinic of Barcelona
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIT-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
Rockefeller UniversityCompletedHIV Infection | Healthy Volunteers | HIV-1 InfectionUnited States
-
Erasmus Medical CenterRecruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Erasmus Medical CenterActive, not recruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
AIDS Healthcare FoundationUniversity of California, Los AngelesCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV-1 Infection | HIV Antibodies | Neutralizing Antibody | Viral Load | Monoclonal AntibodyUnited States
Clinical Trials on Plasma infusion
-
The University of The West IndiesUnknownCOVID-19, Convalescent Plasma TreatmentJamaica
-
Mayo ClinicEnrolling by invitationMild Cognitive ImpairmentUnited States
-
Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingInfertility, Female | Perimenopausal Disorder | Menstrual Cycle AbnormalGreece
-
Thomas BenfieldTerminatedCOVID | Corona Virus Infection | Viral PneumoniaDenmark
-
Reproductive Medicine Associates of New JerseyRecruitingInfertility of Uterine OriginUnited States
-
Jason SperryVanderbilt University; University of Texas; Case Western Reserve University; University... and other collaboratorsCompletedHemmorhagic Shock During Air Medical TransportUnited States
-
University of California, San FranciscoTerminatedInfertility | Asherman's SyndromeUnited States
-
St. Olavs HospitalNorwegian University of Science and TechnologyWithdrawnPurpura, Thrombotic Thrombocytopenic
-
Centro de Educación Medica e Investigaciones Clínicas...Completed