HIV InfectionsNCT00002017
Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
A study testing Interleukin-2, Polyethylene Glycolated in people with HIV Infections, run by Rockefeller University at 1 site in United States.
Trial summary
To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). 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, Polyethylene Glycolated
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- Necessary topical agents such as nystatin, clotrimazole, and acyclovir.
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Oral antibiotics for PCP prophylaxis if hematologically stable for = or > 30 days prior to study entry.
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- Necessary systemic agents for the treatment of other chronic disorders, such as diabetes or asthma.
- Patients must have:
- HIV-1 seropositivity.
- Asymptomatic.
- No opportunistic infection for 8 weeks prior to study entry.
- Been on azidothymidine (AZT) (= or > 500 mg/day) for at least 8 weeks prior to beginning interleukin-2 (IL-2), with stable CD4 cell counts.
- Prior Medication:
- Allowed:
- Zidovudine (AZT).
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Active, life-threatening opportunistic infection (OI) with bacterial, viral, fungal, or protozoan pathogens.
- Fever = or > 101 F. within 10 days prior to study entry.
- Significant central nervous system (CNS) disease including AIDS dementia, psychiatric disability, or seizure disorder.
- Significant cardiac disease (New York Heart Association Stage III or IV).
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- Significant pulmonary disease (Forced Expiratory Volume < 75 percent.
- Weight loss = or > 10 percent within last 3 months.
- Concurrent Medication:
- Excluded:
- Systemic therapy for opportunistic infection (OI).
- Patients with the following are excluded:
- Presence of antibody to interleukin-2 (IL-2).
- Diseases or symptoms listed in Exclusion Co-Existing Conditions.
- Prior Medication:
- Excluded within 12 weeks prior to study entry:
- Other immunomodulators.
- Corticosteroids.
- Other experimental therapy.
- Anti-neoplastic chemotherapy.
- Active drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.
Read the detailed description
Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.
In the first, dose-escalation phase of the study, PEG-IL-2 is injected into the skin of the back by either the intradermal (ID) or subcutaneous (SC) route, to establish an optimal dose (which when given ID results in local induration = or > 25 mm without significant toxicity). The ID and SC routes are compared for systemic effect and toxicity. In the second phase of the study, the PEG-IL-2 is administered for 6-8 weeks using the optimal dosage, frequency, and route determined in the initial phase (probably 2-3 times per week) while local and systemic effects are monitored. These include measures of viral titer, peripheral blood mononuclear cell phenotype, CBC and CD4 counts, and in vitro cytotoxicity assays.
- Conditions
- HIV Infections
- Being tested
- Interleukin-2, Polyethylene Glycolated
- Keywords
- Polyethylene Glycols, Interleukin-2
- 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-2, Polyethylene GlycolatedDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002017
- Sponsor's protocol ID
- 072A
- Other IDs
- COH-010-0790
- Status last verified
- Aug 1991
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Teppler H, Montana A, Meyn P, Kaplan G, Cohn ZA. Prolonged immunostimulatory effect of low dose PEG interleukin-2 in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(2):B162 (abstract no PoB 3453)
Zhang W, Ruan J, Zhang R, Zhang M, Hu X, Han Z, Ruan Q. Association between age-related hearing loss with tinnitus and cognitive performance in older community-dwelling Chinese adults. Psychogeriatrics. 2022 Nov;22(6):822-832. doi: 10.1111/psyg.12889. Epub 2022 Sep 8.
PubMed 36075585Zhang W, Ruan J, Zhang R, Zhang M, Hu X, Yu Z, Han Z, Ruan Q. Age-Related Hearing Loss With Tinnitus and Physical Frailty Influence the Overall and Domain-Specific Quality of Life of Chinese Community-Dwelling Older Adults. Front Med (Lausanne). 2021 Oct 21;8:762556. doi: 10.3389/fmed.2021.762556. eCollection 2021.
PubMed 34746196Ruan Q, Chen J, Zhang R, Zhang W, Ruan J, Zhang M, Han C, Yu Z. Heterogeneous Influence of Frailty Phenotypes in Age-Related Hearing Loss and Tinnitus in Chinese Older Adults: An Explorative Study. Front Psychol. 2021 Feb 16;11:617610. doi: 10.3389/fpsyg.2020.617610. eCollection 2020.
PubMed 33664689
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
- ClinicalTrials.gov ID
- NCT00002017
- Acronym / sponsor ID
- 072A
- Conditions
- HIV Infections
- Keywords
- Polyethylene Glycols, Interleukin-2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- 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 evaluate the safety and immunological effects of polyethylene glycolated-interleukin-2 (PEG-IL-2) on asymptomatic (without symptoms) HIV-seropositive patients who are taking zidovudine (AZT). To enhance measures of immune function with well-tolerated doses of PEG-IL-2, an immunomodulator, in a regimen designed to allow its use in outpatients with normal daily activity (i.e., full-time employment, etc.). Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.
Detailed description
Recombinant IL-2 (without PEG modification) was administered to HIV-infected patients by daily intradermal injection. At the low doses used, this was non-toxic, well-tolerated, and gave a systemic response as measured by natural killer cell and lymphokine-activated killer cell activity, but required daily administration. In the current study, the PEG modification of IL-2 is used since it has a much longer prolonged half-life compared with the non-PEG compound, without loss of functional activity.
In the first, dose-escalation phase of the study, PEG-IL-2 is injected into the skin of the back by either the intradermal (ID) or subcutaneous (SC) route, to establish an optimal dose (which when given ID results in local induration = or > 25 mm without significant toxicity). The ID and SC routes are compared for systemic effect and toxicity. In the second phase of the study, the PEG-IL-2 is administered for 6-8 weeks using the optimal dosage, frequency, and route determined in the initial phase (probably 2-3 times per week) while local and systemic effects are monitored. These include measures of viral titer, peripheral blood mononuclear cell phenotype, CBC and CD4 counts, and in vitro cytotoxicity assays.
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 (15 listed)
- Zidovudine (AZT).
- Necessary topical agents such as nystatin, clotrimazole, and acyclovir.
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Oral antibiotics for PCP prophylaxis if hematologically stable for = or > 30 days prior to study entry.
- Necessary systemic agents for the treatment of other chronic disorders, such as diabetes or asthma.
Key exclusion criteria (21 listed)
- Active, life-threatening opportunistic infection (OI) with bacterial, viral, fungal, or protozoan pathogens.
- Fever = or > 101 F. within 10 days prior to study entry.
- Significant central nervous system (CNS) disease including AIDS dementia, psychiatric disability, or seizure disorder.
- Significant cardiac disease (New York Heart Association Stage III or IV).
- Significant pulmonary disease (Forced Expiratory Volume < 75 percent.
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-2, Polyethylene Glycolated | 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 24 Jun 2005.
- BackgroundTeppler H, Montana A, Meyn P, Kaplan G, Cohn ZA. Prolonged immunostimulatory effect of low dose PEG interleukin-2 in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(2):B162 (abstract no PoB 3453)
- Derived from this study: PubMed 36075585Zhang W, Ruan J, Zhang R, Zhang M, Hu X, Han Z, Ruan Q. Association between age-related hearing loss with tinnitus and cognitive performance in older community-dwelling Chinese adults. Psychogeriatrics. 2022 Nov;22(6):822-832. doi: 10.1111/psyg.12889. Epub 2022 Sep 8.
- Derived from this study: PubMed 34746196Zhang W, Ruan J, Zhang R, Zhang M, Hu X, Yu Z, Han Z, Ruan Q. Age-Related Hearing Loss With Tinnitus and Physical Frailty Influence the Overall and Domain-Specific Quality of Life of Chinese Community-Dwelling Older Adults. Front Med (Lausanne). 2021 Oct 21;8:762556. doi: 10.3389/fmed.2021.762556. eCollection 2021.
- Derived from this study: PubMed 33664689Ruan Q, Chen J, Zhang R, Zhang W, Ruan J, Zhang M, Han C, Yu Z. Heterogeneous Influence of Frailty Phenotypes in Age-Related Hearing Loss and Tinnitus in Chinese Older Adults: An Explorative Study. Front Psychol. 2021 Feb 16;11:617610. doi: 10.3389/fpsyg.2020.617610. eCollection 2020.
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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 study testing Interleukin-2, Polyethylene Glycolated in people with HIV Infections, run by Rockefeller University 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 15 inclusion and 21 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 24 Jun 2005. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002017, which also lists 4 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 24 Jun 2005.