HIV InfectionsPhase 2NCT00000820
A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
A Phase 2 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
PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. 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
- 104 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento Mar 2002
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- PCP prophylaxis.
- Therapy for an opportunistic infection that develops on study, with the exception of foscarnet for CMV disease or resistant Herpes simplex.
- Systemic corticosteroids ONLY IF given for no longer than 21 days for acute PCP.
- Topical corticosteroids to areas separate from a skin test or IL-2 injection site.
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- Acyclovir up to 1000 mg/day as maintenance for recurrent genital Herpes.
- Erythropoietin and filgrastim.
- Antiemetics.
- Antibiotics as clinically indicated.
- Elective standard immunizations at week 8 or later.
- Concurrent Treatment:
- Allowed:
- Local radiation therapy.
- Prior Medication: Required:
- Stable, approved antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry.
- Patients must have:
- HIV seropositivity.
- CD4 count 300 - 700 cells/mm3.
- Stable antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry.
- No history of AIDS-defining illness except for limited cutaneous Kaposi's sarcoma.
- Normal EKG (isolated nonspecific ST and T wave changes permitted).
- NOTE:
- This protocol is approved for prisoner participation.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancy requiring systemic or local cytotoxic chemotherapy.
- Untreated thyroid disease.
- Asthma requiring intermittent or chronic inhalation or systemic therapy.
- Any medical condition that precludes study entry.
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- Concurrent Medication:
- Excluded:
- Antianginal agents such as nitrates, calcium channel blockers, beta blockers, and antiarrhythmics.
- Systemic or local cytotoxic chemotherapy.
- Interferons.
- Interleukins other than study drug.
- Pentoxifylline ( Trental ).
- Acetylcysteine ( NAC ).
- Sargramostim ( GM-CSF ).
- Dinitrochlorobenzene ( DCNB ).
- Thymosin alpha 1.
- Thymopentin.
- Inosiplex ( Isoprinosine ).
- Polyribonucleoside ( Ampligen ).
- Ditiocarb sodium ( Imuthiol ).
- Therapeutic HIV vaccines.
- Investigational antiretroviral agents such as lamivudine ( 3TC ) and tat and protease inhibitors.
- Foscarnet.
- Aspirin.
- Immune globulin ( IVIG ).
- Thalidomide.
- Systemic corticosteroids (permitted for 21 days or less for PCP treatment only).
- Concurrent Treatment:
- Excluded:
- Ongoing transfusion.
- Patients with the following prior conditions are excluded:
- History of autoimmune disease, including inflammatory bowel disease and psoriasis (although autoimmune thyroid disease that is stable is allowed).
- Clinically significant CNS disease or seizures that have been active within 1 year prior to study entry.
- Prior Medication:
- Excluded:
- IL-2 within 3 months prior to study entry.
- Any immunomodulatory therapy within 4 weeks prior to study entry.
- Foscarnet within 4 weeks prior to study entry.
- Acute therapy for an opportunistic infection within 14 days prior to study entry.
- Active alcohol or substance abuse that would compromise study compliance.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Unc Aids Crs
Chapel Hill, North Carolina, 275997215
Case CRS
Cleveland, Ohio, 44106
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Cornell University A2201
New York, New York, 10021
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
About this study
PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone.
SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines.
The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Read the detailed description
The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Patients are randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks, after which each group is crossed over to the other treatment assignment (i.e., IL-2 is either added or deleted from the regimen) for an additional 24 weeks. Patients who are vaccine eligible receive influenza, tetanus and diphtheria toxoid, and meningococcal polysaccharide vaccines at week 4, and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8.
- Conditions
- HIV Infections
- Being tested
- Aldesleukin
- Keywords
- Interleukin-2, Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents
- 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 (1)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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 104 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Teppler H, Study chairPomerantz R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000820
- Sponsor's protocol ID
- ACTG 248
- Other IDs
- 11225
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Publications
Vogler MA, Teppler H, Gelman R, Valentine F, Lederman MM, Pomerantz RJ, Pollard RB, Cherng DW, Gonzalez CJ, Squires KE, Frank I, Mildvan D, Mahon LF, Schock B; AIDS Clinical Trials Group 248 Study Team. Daily low-dose subcutaneous interleukin-2 added to single- or dual-nucleoside therapy in HIV infection does not protect against CD4+ T-cell decline or improve other indices of immune function: results of a randomized controlled clinical trial (ACTG 248). J Acquir Immune Defic Syndr. 2004 May 1;36(1):576-87. doi: 10.1097/00126334-200405010-00005.
PubMed 15097300
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00000820
- Acronym / sponsor ID
- ACTG 248
- Conditions
- HIV Infections
- Keywords
- Interleukin-2, Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 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.
PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone.
SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines.
The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Detailed description
The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.
Patients are randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks, after which each group is crossed over to the other treatment assignment (i.e., IL-2 is either added or deleted from the regimen) for an additional 24 weeks. Patients who are vaccine eligible receive influenza, tetanus and diphtheria toxoid, and meningococcal polysaccharide vaccines at week 4, and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- PCP prophylaxis.
- Therapy for an opportunistic infection that develops on study, with the exception of foscarnet for CMV disease or resistant Herpes simplex.
- Systemic corticosteroids ONLY IF given for no longer than 21 days for acute PCP.
- Topical corticosteroids to areas separate from a skin test or IL-2 injection site.
- Acyclovir up to 1000 mg/day as maintenance for recurrent genital Herpes.
Key exclusion criteria (41 listed)
- Malignancy requiring systemic or local cytotoxic chemotherapy.
- Untreated thyroid disease.
- Asthma requiring intermittent or chronic inhalation or systemic therapy.
- Any medical condition that precludes study entry.
- Antianginal agents such as nitrates, calcium channel blockers, beta blockers, and antiarrhythmics.
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 28 Oct 2021.
- Background: PubMed 15097300Vogler MA, Teppler H, Gelman R, Valentine F, Lederman MM, Pomerantz RJ, Pollard RB, Cherng DW, Gonzalez CJ, Squires KE, Frank I, Mildvan D, Mahon LF, Schock B; AIDS Clinical Trials Group 248 Study Team. Daily low-dose subcutaneous interleukin-2 added to single- or dual-nucleoside therapy in HIV infection does not protect against CD4+ T-cell decline or improve other indices of immune function: results of a randomized controlled clinical trial (ACTG 248). J Acquir Immune Defic Syndr. 2004 May 1;36(1):576-87. doi: 10.1097/00126334-200405010-00005.
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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.
Teppler H study chair
Pomerantz R study chair
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 24 inclusion and 41 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 28 Oct 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000820, which also lists 1 linked publication.
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 28 Oct 2021.