HIV InfectionsNCT00311688
Umbrella Study for HIV Infected Adults Enrolled in NIAID-Funded Interleukin-2 Studies
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Interleukin-2 (IL-2) is a protein found naturally in the blood that helps boost the immune system. The purpose of this study is to provide long-term treatment and monitoring of HIV infected people enrolled in NIAID-funded studies investigating the use of laboratory-made IL-2 for the treatment of HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Interleukin-2
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 2008
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
- Current participation and presently in good standing in a NIAID/CCMD clinical trial involving the use of IL-2 for the treatment of HIV-1 infection. Additional HIV-1 infected people who are IL-2 naive may be selected by the investigator for this study.
- Willing to take antiretrovirals within a 10-day period surrounding each IL-2 cycle. Individual protocols may be modified as needed by the investigator to permit IL-2 therapy in the absence of antiretrovirals.
- Willing to accept additional IL-2 therapy when needed
- Willing to use acceptable forms of contraception during a minimum 10-day period surrounding each IL-2 injection
Who cannot join
- History of noncompliance with prior NIAID/CCMD protocols
- Any organic central nervous system (CNS) abnormality requiring treatment with antiseizure medication
- Unless previously exempted for this requirement, current or history of Crohn's disease, psoriasis, or other autoimmune or inflammatory disease with potentially life-threatening complications
- Significant heart, lung, kidney, rheumatologic, gastrointestinal, or CNS disease that may pose an unacceptable risk to the participant during IL-2 therapy
- Psychiatric illness that, in the opinion of the investigator, may interfere with the study
- Current or recent substance abuse that, in the opinion of the investigator, may interfere with the study
Show all 9Show fewer
- Refuse to follow Clinical Center policy on partner notification
- History of optic neuritis
- Refuse to allow extra blood specimens to be stored for potential use in future studies of HIV-1 infection or the immune system
Trial locations and contacts
1 site in 1 country.
United States1 site
NIH Intramural Research Program ACTG CRS
Bethesda, Maryland, 20892
About this study
Official title: An Omnibus Proleukin (IL-2) Trial in HIV Infected Patients Including Interrupted Versus Continuous Antiretrovirals (OPTICA)
Interleukin-2 (IL-2) is a protein found naturally in the blood that helps boost the immune system. The purpose of this study is to provide long-term treatment and monitoring of HIV infected people enrolled in NIAID-funded studies investigating the use of laboratory-made IL-2 for the treatment of HIV infection.
Read the detailed description
IL-2 is a biological response modifier that can improve the body's response to disease. It is hoped that IL-2 treatment can help restore CD4 cell counts and immune function in people whose immune systems have been damaged by HIV. Over the last 10 years, NIAID has sponsored a number of important studies of IL-2 in HIV infected people; many of these trials are ongoing. This study was developed in an effort consolidate these separate, smaller trials into one larger study so that results between the trials can be shared and used to develop future protocols. This study is an umbrella study that will provide long-term administrative support, treatment, and monitoring for ongoing Phase I and II IL-2 trials and their participants. It is primarily intended for patients in the extension phases of any previous NIAID Clinical Center HIV Program (NIAID/CCMD) intramural research protocols in which IL-2 therapy continues to be offered. Blood collection will occur through a patient's participation in this study.
Participants will continue to follow the protocol in which they originally enrolled. A desired therapeutic goal or "CD4 plateau" will be used in most cases to help clinicians determine when a participant requires additional IL-2. In general, if a participant has two or more consecutive CD4 counts below the CD4 plateau, additional IL-2 will be administered to that patient. In maintaining uniformity among the many trials being consolidated under this trial, the frequency and nature of study visits will be solely dictated by this umbrella study. Participants will also be asked to join an optional substudy: Interrupted Versus Continuous Antiretrovirals Involving Randomization from the Umbrella Study (ICARUS).
- Conditions
- HIV Infections
- Being tested
- Interleukin-2
- Keywords
- IL-2, Immunomodulatory Therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2Drug
Also called IL-2
Biological response modifier in liquid form; dosage of drug will vary by study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals will follow the schedule of the study they are participating in Receives: Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 counts in participants treated with IL-2 and discontinued antiretroviral therapy
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startDec 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Time perspective
- Prospective
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard T. Davey, Jr., MD, FACP, Study chair, NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311688
- Sponsor's protocol ID
- IRP 030/OPTICA
- Other IDs
- 10476, IRP 030, OPTICA
- Status last verified
- Oct 2021
- First submitted
- 4 Apr 2006
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Anaya JP, Sias JJ. The use of interleukin-2 in human immunodeficiency virus infection. Pharmacotherapy. 2005 Jan;25(1):86-95. doi: 10.1592/phco.25.1.86.55629.
PubMed 15767224Marchetti G, Franzetti F, Gori A. Partial immune reconstitution following highly active antiretroviral therapy: can adjuvant interleukin-2 fill the gap? J Antimicrob Chemother. 2005 Apr;55(4):401-9. doi: 10.1093/jac/dkh557. Epub 2005 Feb 24.
PubMed 15731201Temesgen Z. Interleukin-2 for the treatment of human immunodeficiency virus infection. Drugs Today (Barc). 2006 Dec;42(12):791-801. doi: 10.1358/dot.2006.42.12.1025703.
PubMed 17285152
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 Omnibus Proleukin (IL-2) Trial in HIV Infected Patients Including Interrupted Versus Continuous Antiretrovirals (OPTICA)
- ClinicalTrials.gov ID
- NCT00311688
- Acronym / sponsor ID
- IRP 030/OPTICA
- Conditions
- HIV Infections
- Keywords
- IL-2, Immunomodulatory Therapies
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Apr 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.
Interleukin-2 (IL-2) is a protein found naturally in the blood that helps boost the immune system. The purpose of this study is to provide long-term treatment and monitoring of HIV infected people enrolled in NIAID-funded studies investigating the use of laboratory-made IL-2 for the treatment of HIV infection.
Detailed description
IL-2 is a biological response modifier that can improve the body's response to disease. It is hoped that IL-2 treatment can help restore CD4 cell counts and immune function in people whose immune systems have been damaged by HIV. Over the last 10 years, NIAID has sponsored a number of important studies of IL-2 in HIV infected people; many of these trials are ongoing. This study was developed in an effort consolidate these separate, smaller trials into one larger study so that results between the trials can be shared and used to develop future protocols. This study is an umbrella study that will provide long-term administrative support, treatment, and monitoring for ongoing Phase I and II IL-2 trials and their participants. It is primarily intended for patients in the extension phases of any previous NIAID Clinical Center HIV Program (NIAID/CCMD) intramural research protocols in which IL-2 therapy continues to be offered. Blood collection will occur through a patient's participation in this study.
Participants will continue to follow the protocol in which they originally enrolled. A desired therapeutic goal or "CD4 plateau" will be used in most cases to help clinicians determine when a participant requires additional IL-2. In general, if a participant has two or more consecutive CD4 counts below the CD4 plateau, additional IL-2 will be administered to that patient. In maintaining uniformity among the many trials being consolidated under this trial, the frequency and nature of study visits will be solely dictated by this umbrella study. Participants will also be asked to join an optional substudy: Interrupted Versus Continuous Antiretrovirals Involving Randomization from the Umbrella Study (ICARUS).
Study design
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Interleukin-2Individuals will follow the schedule of the study they are participating in |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1 infected
- Current participation and presently in good standing in a NIAID/CCMD clinical trial involving the use of IL-2 for the treatment of HIV-1 infection. Additional HIV-1 infected people who are IL-2 naive may be selected by the investigator for this study.
- Willing to take antiretrovirals within a 10-day period surrounding each IL-2 cycle. Individual protocols may be modified as needed by the investigator to permit IL-2 therapy in the absence of antiretrovirals.
- Willing to accept additional IL-2 therapy when needed
- Willing to use acceptable forms of contraception during a minimum 10-day period surrounding each IL-2 injection
Key exclusion criteria (9 listed)
- History of noncompliance with prior NIAID/CCMD protocols
- Any organic central nervous system (CNS) abnormality requiring treatment with antiseizure medication
- Unless previously exempted for this requirement, current or history of Crohn's disease, psoriasis, or other autoimmune or inflammatory disease with potentially life-threatening complications
- Significant heart, lung, kidney, rheumatologic, gastrointestinal, or CNS disease that may pose an unacceptable risk to the participant during IL-2 therapy
- Psychiatric illness that, in the opinion of the investigator, may interfere with 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 |
|---|---|---|
| Interleukin-2Also: IL-2Biological response modifier in liquid form; dosage of drug will vary by study | Drug | 1 |
Primary outcome
CD4 counts in participants treated with IL-2 and discontinued antiretroviral therapy
Time frame: Throughout study
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 15767224Anaya JP, Sias JJ. The use of interleukin-2 in human immunodeficiency virus infection. Pharmacotherapy. 2005 Jan;25(1):86-95. doi: 10.1592/phco.25.1.86.55629.
- Background: PubMed 15731201Marchetti G, Franzetti F, Gori A. Partial immune reconstitution following highly active antiretroviral therapy: can adjuvant interleukin-2 fill the gap? J Antimicrob Chemother. 2005 Apr;55(4):401-9. doi: 10.1093/jac/dkh557. Epub 2005 Feb 24.
- Background: PubMed 17285152Temesgen Z. Interleukin-2 for the treatment of human immunodeficiency virus infection. Drugs Today (Barc). 2006 Dec;42(12):791-801. doi: 10.1358/dot.2006.42.12.1025703.
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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 T. Davey, Jr., MD, FACP study chair
NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 inclusion and 9 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 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.
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?
CD4 counts in participants treated with IL-2 and discontinued antiretroviral therapy (time frame: Throughout study). 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 NCT00311688, which also lists 3 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.