HIV InfectionsNCT00038259
Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy
A study testing Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV. This may lead to the body mounting a better immune response against the virus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Aldesleukin
- How many people
- 21 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento May 2006
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV infected
- CD4 cell count of 300 cells/mm3 or more within 30 days prior to study entry
- HIV viral load of less than 50 copies/ml within 30 days prior to study entry
- Anti-HIV drug regimen of at least 3 anti-HIV drugs for at least 6 months immediately prior to study entry
- Documented pretherapy plasma HIV viral load measured within 6 months of starting ART
- Willing to use acceptable methods of contraception
Who cannot join
- HIV viral load of 50 copies/ml or more within 60 days before study entry
- Current use of experimental anti-HIV drugs other than FDA sanctioned investigational drugs
- Abacavir as part of anti-HIV regimen within 8 weeks prior to study entry
- Pregnant or breastfeeding
- History of autoimmune disease, except for stable autoimmune thyroid disease
- Heart problems or on certain medications for treatment of heart problems
Show all 16Show fewer
- Cancer requiring chemotherapy
- Untreated thyroid disease
- Disease of the central nervous system that has been active within 1 year prior to study entry
- Uncontrolled diabetes
- Allergies to the study medications
- Other illnesses that would make it inappropriate for patients to participate in the study
- Immunomodulatory therapy within 4 weeks prior to study entry
- Hydroxyurea within 6 months prior to study entry
- Drug or alcohol use that, in the opinion of the investigator, would interfere with the study
- Psychiatric or mental impairment that would affect compliance
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
MetroHealth CRS
Cleveland, Ohio
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 775550435
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
UCLA CARE Center CRS
Los Angeles, California, 90502
Univ. of Miami AIDS CRS
Miami, Florida, 33136-1013
Stanford CRS
Palo Alto, California, 94305-5107
UC Davis Medical Center
Sacramento, California, 95814
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, 95814
Santa Clara Valley Med. Ctr.
San Jose, California, 94305-5107
San Mateo County AIDS Program
San Mateo, California, 94305-5107
About this study
Official title: An Exploratory, Open-Label, Randomized Trial to Evaluate the Ability of Interleukin-2 (IL-2) to Enhance HIV-Specific Immunity and Influence the Time to Virologic Relapse Following Withdrawal of Potent Antiretroviral Therapy
When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV. This may lead to the body mounting a better immune response against the virus. The purpose of this study is to find out if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for short periods of time can help patients control their HIV viral load.
Study hypothesis: Patients in this study will have lower virologic rebound and will maintain their CD4 cell counts for a longer time than other patients in comparative studies.
Read the detailed description
Structured treatment interruptions (STIs) may stimulate an anti-HIV immune response. Evidence suggests that IL-2, which increases CD4 counts, could also enhance specific immune responses to HIV. Enhanced immune responses could influence the magnitude of and the time to virologic rebound following treatment discontinuation. This study will compare the viral loads present after 12 weeks of an antiretroviral therapy (ART) interruption period between patients who have received different dosing regimens of IL-2 and have taken part in at least two STIs.
This study will last 40 to 104 weeks. IL-2 is provided as part of this study; potent ART is not provided. Patients in this study will receive potent ART with at least two scheduled potent ART interruptions. Patients will be randomly assigned to one of two treatment arms. Arm A patients will receive low-dose injections of IL-2 for 3 weeks, during the last 2 weeks of potent ART interruption periods and the first week of restarting potent ART. Arm B patients will receive high-dose injections of IL-2 during the first 5 days of restarting potent ART after the interruption period. The first two ART interruptions are 4 weeks in duration, followed by 12 weeks back on ART. Depending on the patient's viral load and CD4 count at Week 32, patients will either enter a third potent ART interruption for 12 to 48 weeks or will continue ART. No IL-2 will be given with the third scheduled potent ART interruption. Throughout the study, participants will have physical exams and laboratory tests, including measurements of viral load and CD4 count.
- Conditions
- HIV Infections
- Being tested
- Aldesleukin
- Keywords
- Interleukin-2, Drug Administration Schedule, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Treatment Interruption, Treatment Experienced, STI
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldesleukinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of log10 HIV-1 RNA copies/ml obtained at Weeks 11 and 12 following the final interruption of potent antiretroviral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard M. Pollard, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038259
- Sponsor's protocol ID
- A5132
- Other IDs
- 10081
- Status last verified
- Oct 2021
- First submitted
- 29 May 2002
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Carr A, Emery S, Lloyd A, Hoy J, Garsia R, French M, Stewart G, Fyfe G, Cooper DA. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group. J Infect Dis. 1998 Oct;178(4):992-9. doi: 10.1086/515653.
PubMed 9806026Kovacs JA, Baseler M, Dewar RJ, Vogel S, Davey RT Jr, Falloon J, Polis MA, Walker RE, Stevens R, Salzman NP, Lane HC. Increases in CD4 T lymphocytes with intermittent courses of interleukin-2 in patients with human immunodeficiency virus infection. A preliminary study. N Engl J Med. 1995 Mar 2;332(9):567-75. doi: 10.1056/NEJM199503023320904.
PubMed 7646637Kovacs JA, Vogel S, Albert JM, Falloon J, Davey RT Jr, Walker RE, Polis MA, Spooner K, Metcalf JA, Baseler M, Fyfe G, Lane HC. Controlled trial of interleukin-2 infusions in patients infected with the human immunodeficiency virus. N Engl J Med. 1996 Oct 31;335(18):1350-6. doi: 10.1056/NEJM199610313351803.
PubMed 8857018Lafeuillade A, Poggi C, Hittinger G, Counillon E, Emilie D. Predictors of plasma human immunodeficiency virus type 1 RNA control after discontinuation of highly active antiretroviral therapy initiated at acute infection combined with structured treatment interruptions and immune-based therapies. J Infect Dis. 2003 Nov 15;188(10):1426-32. doi: 10.1086/379251. Epub 2003 Oct 27.
PubMed 14624367Pett SL, Kelleher AD. Cytokine therapies in HIV-1 infection: present and future. Expert Rev Anti Infect Ther. 2003 Jun;1(1):83-96. doi: 10.1586/14787210.1.1.83.
PubMed 15482104Bosch RJ, Pollard RB, Landay A, Aga E, Fox L, Mitsuyasu R; AIDS Clinical Trials Group A5132 Team. A randomized trial of interleukin-2 during withdrawal of antiretroviral treatment. J Interferon Cytokine Res. 2011 Jun;31(6):481-3. doi: 10.1089/jir.2010.0119. Epub 2011 Feb 3.
PubMed 21291323
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-Label, Randomized Trial to Evaluate the Ability of Interleukin-2 (IL-2) to Enhance HIV-Specific Immunity and Influence the Time to Virologic Relapse Following Withdrawal of Potent Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00038259
- Acronym / sponsor ID
- A5132
- Conditions
- HIV Infections
- Keywords
- Interleukin-2, Drug Administration Schedule, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Treatment Interruption, Treatment Experienced, STI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2006 (actual)
- First posted
- 30 May 2002 (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.
When an HIV infected person taking strong anti-HIV drugs temporarily stops taking them, viral load rises and the body's immune system is exposed to more HIV. This may lead to the body mounting a better immune response against the virus. The purpose of this study is to find out if taking interleukin-2 (also called IL-2 or aldesleukin) while stopping anti-HIV drugs for short periods of time can help patients control their HIV viral load.
Study hypothesis: Patients in this study will have lower virologic rebound and will maintain their CD4 cell counts for a longer time than other patients in comparative studies.
Detailed description
Structured treatment interruptions (STIs) may stimulate an anti-HIV immune response. Evidence suggests that IL-2, which increases CD4 counts, could also enhance specific immune responses to HIV. Enhanced immune responses could influence the magnitude of and the time to virologic rebound following treatment discontinuation. This study will compare the viral loads present after 12 weeks of an antiretroviral therapy (ART) interruption period between patients who have received different dosing regimens of IL-2 and have taken part in at least two STIs.
This study will last 40 to 104 weeks. IL-2 is provided as part of this study; potent ART is not provided. Patients in this study will receive potent ART with at least two scheduled potent ART interruptions. Patients will be randomly assigned to one of two treatment arms. Arm A patients will receive low-dose injections of IL-2 for 3 weeks, during the last 2 weeks of potent ART interruption periods and the first week of restarting potent ART. Arm B patients will receive high-dose injections of IL-2 during the first 5 days of restarting potent ART after the interruption period. The first two ART interruptions are 4 weeks in duration, followed by 12 weeks back on ART. Depending on the patient's viral load and CD4 count at Week 32, patients will either enter a third potent ART interruption for 12 to 48 weeks or will continue ART. No IL-2 will be given with the third scheduled potent ART interruption. Throughout the study, participants will have physical exams and laboratory tests, including measurements of viral load and CD4 count.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- HIV infected
- CD4 cell count of 300 cells/mm3 or more within 30 days prior to study entry
- HIV viral load of less than 50 copies/ml within 30 days prior to study entry
- Anti-HIV drug regimen of at least 3 anti-HIV drugs for at least 6 months immediately prior to study entry
- Documented pretherapy plasma HIV viral load measured within 6 months of starting ART
Key exclusion criteria (16 listed)
- HIV viral load of 50 copies/ml or more within 60 days before study entry
- Current use of experimental anti-HIV drugs other than FDA sanctioned investigational drugs
- Abacavir as part of anti-HIV regimen within 8 weeks prior to study entry
- Pregnant or breastfeeding
- History of autoimmune disease, except for stable autoimmune thyroid disease
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 |
|---|---|---|
| Aldesleukin | Drug | – |
Primary outcome
Mean of log10 HIV-1 RNA copies/ml obtained at Weeks 11 and 12 following the final interruption of potent antiretroviral therapy
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 1 Nov 2021.
- Background: PubMed 9806026Carr A, Emery S, Lloyd A, Hoy J, Garsia R, French M, Stewart G, Fyfe G, Cooper DA. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group. J Infect Dis. 1998 Oct;178(4):992-9. doi: 10.1086/515653.
- Background: PubMed 7646637Kovacs JA, Baseler M, Dewar RJ, Vogel S, Davey RT Jr, Falloon J, Polis MA, Walker RE, Stevens R, Salzman NP, Lane HC. Increases in CD4 T lymphocytes with intermittent courses of interleukin-2 in patients with human immunodeficiency virus infection. A preliminary study. N Engl J Med. 1995 Mar 2;332(9):567-75. doi: 10.1056/NEJM199503023320904.
- Background: PubMed 8857018Kovacs JA, Vogel S, Albert JM, Falloon J, Davey RT Jr, Walker RE, Polis MA, Spooner K, Metcalf JA, Baseler M, Fyfe G, Lane HC. Controlled trial of interleukin-2 infusions in patients infected with the human immunodeficiency virus. N Engl J Med. 1996 Oct 31;335(18):1350-6. doi: 10.1056/NEJM199610313351803.
- Background: PubMed 14624367Lafeuillade A, Poggi C, Hittinger G, Counillon E, Emilie D. Predictors of plasma human immunodeficiency virus type 1 RNA control after discontinuation of highly active antiretroviral therapy initiated at acute infection combined with structured treatment interruptions and immune-based therapies. J Infect Dis. 2003 Nov 15;188(10):1426-32. doi: 10.1086/379251. Epub 2003 Oct 27.
- Background: PubMed 15482104Pett SL, Kelleher AD. Cytokine therapies in HIV-1 infection: present and future. Expert Rev Anti Infect Ther. 2003 Jun;1(1):83-96. doi: 10.1586/14787210.1.1.83.
- Derived from this study: PubMed 21291323Bosch RJ, Pollard RB, Landay A, Aga E, Fox L, Mitsuyasu R; AIDS Clinical Trials Group A5132 Team. A randomized trial of interleukin-2 during withdrawal of antiretroviral treatment. J Interferon Cytokine Res. 2011 Jun;31(6):481-3. doi: 10.1089/jir.2010.0119. Epub 2011 Feb 3.
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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.
Richard M. Pollard, MD study chair
University of California, Davis
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites 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 6 inclusion and 16 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
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 of log10 HIV-1 RNA copies/ml obtained at Weeks 11 and 12 following the final interruption of potent antiretroviral therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00038259, which also lists 6 linked publications.
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 1 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.