HIV InfectionPhase 2/3NCT00353327
Study of the Effectiveness of Passive Immunotherapy in HIV-Infected Patients Who Are in Virologic Failure
A Phase 2/3 study testing Plasma infusion in people with HIV Infection, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Plasma infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2006to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment. Randomized Study in Two Phases.
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- Plasma infusion
- Keywords
- HIV, Passive immunotherapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma infusionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Toxicity
Accomplishment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startOct 2006
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Felipe Garcia, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353327
- Sponsor's protocol ID
- PIT-01
- Status last verified
- Mar 2008
- First submitted
- 17 Jul 2006
- Last updated
- 31 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Immunotherapy in HIV-Infected Patients Who Fail to Respond to Multiple Highly Active Antiretroviral Treatment. Randomized Study in Two Phases.
- ClinicalTrials.gov ID
- NCT00353327
- Acronym / sponsor ID
- PIT-01
- Conditions
- HIV Infection
- Keywords
- HIV, Passive immunotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: low recruitment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 18 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma infusion | Procedure or surgery | – |
Primary outcome
Lowering of plasma viral load after the first plasma infusion
Lowering of plasma viral load after a year
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Garcia, MD, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Plasma infusion in people with HIV Infection, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowering of plasma viral load after the first plasma infusion. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2008.