HIV InfectionsPhase 2NCT00013663
Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
A Phase 2 study testing ALVAC(2)120(B,MN)GNP (vCP1452) and Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to determine if HIV-specific canarypox vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- ALVAC(2)120(B,MN)GNP (vCP1452) and Aldesleukin
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2006
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are more than 18 years old.
- Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months.
- Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry.
- Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry.
- Have not had virologic failure on the current HAART regimen.
- Have a negative urine pregnancy test within 14 days of entering the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have a current AIDS-defining illness.
- Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml).
- Have a history of using agents affecting the immune system.
- Have active uncontrolled heart disease.
- Have had IL-2 therapy within 4 weeks of entering the study.
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- Have received other treatment that affects the immune system within 4 weeks of entry.
- Have a history of a cancer requiring chemotherapy.
- Have untreated thyroid disease, within 4 weeks of entering the study.
- Have uncontrolled allergic disorders or autoimmune diseases, including asthma, inflammatory bowel disease, and psoriasis.
- Abuse substances that may interfere with the ability to follow study requirements.
- Are allergic to eggs.
- Have hepatitis B or hepatitis C.
- Are pregnant or breast-feeding.
- Work in close contact with canaries, such as a job at breeding farms or bird shops.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Hosp - Cornell Med Ctr
New York, New York, 10021
About this study
Official title: A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy
The purpose of this study is to determine if HIV-specific canarypox vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.
Read the detailed description
Step I: In addition to continuing HAART, patients are randomized into 1 of the following 4 arms:
A: Immunization placebo; B: Immunization with the canarypox HIV-vaccine (vCP1452); C: Daily low-dose IL-2 + immunization placebo; or D: Daily low-dose IL-2 + canarypox HIV-vaccine (vCP1452). Patients on Arms A, B, C, and D receive vaccine (or vaccine placebo) injections at Weeks 0, 4, 8, and 12. Patients on Arms C and D receive IL-2 by self-injection. HAART is not provided as part of this study.
Step II: Patients on all arms (A, B, C, and D) who meet inclusion criteria advance to Step II and interrupt HAART for a minimum of 12 weeks. The efficacy of these immunological therapies will be determined by monitoring the dynamics of viral rebound upon cessation of antiviral therapy. After 12 weeks of Step II, patients whose viral load remains below 30,000 copies/ml remain on Step II, off HAART, and continue weekly viral load monitoring. Patients will not terminate Step II or resume HAART unless and until their viral load increases to more than 30,000 copies/ml on 3 successive determinations, or their CD4 count decreases to less than 200 cells/mm3 or less than 50 percent of the baseline CD4+ T cell concentration on 2 successive occasions.
- Conditions
- HIV Infections
- Being tested
- ALVAC(2)120(B,MN)GNP (vCP1452), Aldesleukin
- Keywords
- Virus Replication, HIV-1, AIDS Vaccines, RNA, Viral, Avipoxvirus, Genetic Vectors, Viral Load, aldesleukin, Antiretroviral Therapy, Highly Active, HIV Therapeutic Vaccine, Treatment Interruption
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALVAC(2)120(B,MN)GNP (vCP1452)Biological
AldesleukinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25 (8 to 12 weeks following HAART interruption
Secondary outcomes (3)
Proportion of participants who relapse during the first 12 weeks following stopping of HAART
length of time to the termination of Step II among participants
changes in frequency, activation state, and HIV-specific functional capacity of T and NK cells in blood, as monitored by expression of intracellular cytokines during the first 12 weeks after stopping HAART, with respect to termination of Step II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 92 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- New York Presbyterian Hospital
- Investigators
- Kendall A. Smith, MD, Principal investigator, Division of Immunology, Department of Medicine, Weill Medical College, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013663
- Sponsor's protocol ID
- B012
- Other IDs
- 0900-397
- Status last verified
- Jun 2006
- First submitted
- 27 Mar 2001
- Last updated
- 2 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Testing the Efficacy of Immunotherapies to Control Plasma HIV RNA Concentrations Upon Interruption of Highly Active Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00013663
- Acronym / sponsor ID
- B012
- Conditions
- HIV Infections
- Keywords
- Virus Replication, HIV-1, AIDS Vaccines, RNA, Viral, Avipoxvirus, Genetic Vectors, Viral Load, aldesleukin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- New York Presbyterian Hospital
- Study completion
- Jun 2006 (actual)
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to determine if HIV-specific canarypox vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.
Detailed description
Step I: In addition to continuing HAART, patients are randomized into 1 of the following 4 arms:
A: Immunization placebo; B: Immunization with the canarypox HIV-vaccine (vCP1452); C: Daily low-dose IL-2 + immunization placebo; or D: Daily low-dose IL-2 + canarypox HIV-vaccine (vCP1452). Patients on Arms A, B, C, and D receive vaccine (or vaccine placebo) injections at Weeks 0, 4, 8, and 12. Patients on Arms C and D receive IL-2 by self-injection. HAART is not provided as part of this study.
Step II: Patients on all arms (A, B, C, and D) who meet inclusion criteria advance to Step II and interrupt HAART for a minimum of 12 weeks. The efficacy of these immunological therapies will be determined by monitoring the dynamics of viral rebound upon cessation of antiviral therapy. After 12 weeks of Step II, patients whose viral load remains below 30,000 copies/ml remain on Step II, off HAART, and continue weekly viral load monitoring. Patients will not terminate Step II or resume HAART unless and until their viral load increases to more than 30,000 copies/ml on 3 successive determinations, or their CD4 count decreases to less than 200 cells/mm3 or less than 50 percent of the baseline CD4+ T cell concentration on 2 successive occasions.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV-positive.
- Are more than 18 years old.
- Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months.
- Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry.
- Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry.
Key exclusion criteria (15 listed)
- Have a current AIDS-defining illness.
- Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml).
- Have a history of using agents affecting the immune system.
- Have active uncontrolled heart disease.
- Have had IL-2 therapy within 4 weeks of entering the study.
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 |
|---|---|---|
| ALVAC(2)120(B,MN)GNP (vCP1452) | Biological | – |
| Aldesleukin | Drug | – |
Primary outcome
Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25 (8 to 12 weeks following HAART interruption
3 secondary outcomes
Proportion of participants who relapse during the first 12 weeks following stopping of HAART
length of time to the termination of Step II among participants
changes in frequency, activation state, and HIV-specific functional capacity of T and NK cells in blood, as monitored by expression of intracellular cytokines during the first 12 weeks after stopping HAART, with respect to termination of Step II
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
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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.
Kendall A. Smith, MD principal investigator
Division of Immunology, Department of Medicine, Weill Medical College, Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALVAC(2)120(B,MN)GNP (vCP1452) and Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 2 Nov 2012. 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean log10 viral load for each experimental group from the average of 5 values obtained during Weeks 21 to 25 (8 to 12 weeks following HAART interruption. 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 2 Nov 2012.