HIV InfectionsPhase 1NCT00000821
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
A Phase 1 study testing Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers. 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?
- Aldesleukin
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2002
- Phase
- Phase 1
- 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
- Patients must have:
- HIV positivity.
- CD4 count >= 500 cells/mm3.
- No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma.
- Concurrent Medication: Required:
- Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T).
- Prior Medication: Required:
- FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Significant cardiac, pulmonary, thyroid, renal, or CNS disease.
- Prior Medication:
- Excluded:
- Prior IL-2.
- Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, 20892
About this study
To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.
Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.
Read the detailed description
Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.
Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.
- Conditions
- HIV Infections
- Being tested
- Aldesleukin
- Keywords
- Interleukin-2, AIDS-Related Complex
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldesleukinDrug
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 completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Enrolment
- 78 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000821
- Sponsor's protocol ID
- IRP 015
- Other IDs
- IL-2 SC, 93-I-0205
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Giedlin M, McGrath M, Gascon R, DeGroat S, Fyfe G, Kahn J. Immunological characterization of HIV seropositive patients treated with subcutaneous Proleukin (aldesleukin) recombinant Interleukin-2. Int Conf AIDS. 1996 Jul 7-12;11(2):282 (abstract no ThB4183)
Davey RT Jr, Chaitt DG, Albert JM, Piscitelli SC, Kovacs JA, Walker RE, Falloon J, Polis MA, Metcalf JA, Masur H, Dewar R, Baseler M, Fyfe G, Giedlin MA, Lane HC. A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type 1 infection. J Infect Dis. 1999 Apr;179(4):849-58. doi: 10.1086/314678.
PubMed 10068580
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00000821
- Acronym / sponsor ID
- IRP 015
- Conditions
- HIV Infections
- Keywords
- Interleukin-2, AIDS-Related Complex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 2002 (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.
To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.
Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.
Detailed description
Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.
Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV positivity.
- CD4 count >= 500 cells/mm3.
- No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma.
- Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T).
- FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry.
Key exclusion criteria (7 listed)
- Significant cardiac, pulmonary, thyroid, renal, or CNS disease.
- Prior IL-2.
- Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.
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
Not reported in the source record.
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 3 Nov 2021.
- BackgroundGiedlin M, McGrath M, Gascon R, DeGroat S, Fyfe G, Kahn J. Immunological characterization of HIV seropositive patients treated with subcutaneous Proleukin (aldesleukin) recombinant Interleukin-2. Int Conf AIDS. 1996 Jul 7-12;11(2):282 (abstract no ThB4183)
- Background: PubMed 10068580Davey RT Jr, Chaitt DG, Albert JM, Piscitelli SC, Kovacs JA, Walker RE, Falloon J, Polis MA, Metcalf JA, Masur H, Dewar R, Baseler M, Fyfe G, Giedlin MA, Lane HC. A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type 1 infection. J Infect Dis. 1999 Apr;179(4):849-58. doi: 10.1086/314678.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 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 7 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 3 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000821, which also lists 2 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 3 Nov 2021.