Acquired Immunodeficiency SyndromePhase 2NCT00001475
Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist
A Phase 2 study testing IL-2 plus Anti-TNF or Thalidomide in people with Acquired Immunodeficiency Syndrome and HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infection
- What is being tested?
- IL-2 plus Anti-TNF or Thalidomide
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1995to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
IL-2 NAIVE PATIENTS:
Documented HIV-1 infection (ELISA and Western blot positive).
18 years or older.
CD4 count greater than or equal to 200 cells per mm(3) and less than or equal to 500 cells/mm(3)
Clinical laboratory values Grade 0 or 1.
No therapy with corticosteroids, chemotherapy, pentoxifylline, thalidomide, or experimental therapy in the prior 4 weeks.
Negative urine pregnancy test within 2 weeks prior to study entry (for women of childbearing potential).
Current treatment with a stable regimen or licensed anti-retroviral therapy for at least 2 weeks.
Adequate venous access in the upper extremities for repeated blood drawing and intravenous catheter placement.
No prior IL-2 therapy.
No malignancy other than Kaposi's sarcoma. Patients with Kaposi's sarcoma are eligible, but most not have received systemic therapy for KS within 4 weeks prior to study entry.
No history of prior AIDS-defining opportunistic infection other than pulmonary TB or recurrent pneumonia.
No active substance abuse which may affect patient safety or compliance.
No patients exhibiting psychiatric disturbance or illness which in the assessment of the protocol team may affect patient safety or compliance.
No patients with significant cardiac, pulmonary, rheumatologic, thyroid, kidney, gastrointestinal or neurological disease that could either decrease absorption of oral therapy, prove a cardiovascular risk during the fluid shifts and stresses that occur with IL-2 therapy, or that could have an inflammatory/immune etiology and thus might be activated or worsened by IL-2.
No patients with hypertension requiring continuous anti-hypertensive therapy.
No pregnant or lactating patients.
Women of childbearing potential must agree to practice abstinence or use 2 forms of contraception simultaneously beginning 1 month prior to receiving study medication and continuing thereafter until 1 month after the last dose of study medication.
Men must agree to practice abstinence or use a condom when engaging in intercourse during the same time period.
Must be willing to comply with current NIH Clinical Center guidelines concerning appropriate notification by an individual of current or ongoing sexual partners and/or needle-sharing partners regarding his or her HIV-1 seropositivity and the risk of transmission of HIV-1 infection.
No history of hypersensitivity or intolerance to either IL-2 or thalidomide.
PRIOR IL-2 THERAPY PATIENTS:
Active participation in protocols 91-CC-0113 or 93-CC-0143.
Negative urine pregnancy test within 2 weeks prior to study entry (for women of childbearing potential).
No history of hypersensitivity or intolerance to thalidomide.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: A Randomized Trial of Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist in Patients With HIV-1 Infection
Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients in this study. Also, certain patients in this protocol may receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle.
To be eligible for home administration of IL-2, patients must:
Read more
- Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol, with at least two well-tolerated outpatient cycles at a stable dose.
- Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions, intravenous fluid replacement or dose reductions.
- Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles.
- Have a strong relationship with a private physician or health-care provider who has been involved in the patient's care and is willing to help supervise the patient's care during each home IL-2 cycle.
- Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff.
- Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle, providing the patient non-medical assistance and checking on his or her condition daily.
- Have reasonable access to emergency medical services and a nearby medical facility.
- Have proved reliable and consistent in using sterile technique, reconstituting IL-2 vials and administering subcutaneous IL-2 injections.
- Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their normal protocol participation.
- Have access to a home weight scale and be able to weigh themselves each day for safety monitoring.
Participants will receive IL-2 cycles on the same schedule they followed in their original protocol participation. They will be seen at the Clinical Center at regularly scheduled follow-up visits between cycles and for a medical evaluation and blood drawing before the start of each cycle to determine the safety of administering the cycle. During the home cycle, the patient's case manager or other team member will place monitoring telephone calls on days 2 and 4 of the cycle and again a week later. The timing and number of these calls may change depending on the findings of ongoing assessments of their usefulness. Patients will be required to notify the study team promptly of any complications or other problems that develop with therapy.
Read the detailed description
In the initial phase of this study, HIV-infected patients with CD4 counts between 200 and 500 were randomized to receive either IL-2 alone by continuous IV infusion for 5 days every 8 weeks, IL-2 plus anti-TNF antibody, or IL-2 plus thalidomide. The primary endpoints of this study are safety and tolerability of the IL-2/TNF inhibitor combination. Secondary endpoints will include changes in CD4 counts, frequency and severity of IL-2 related side effects, changes in serum TNF levels, and plasma viral load changes. The study period is one year, with an optional extension period to follow. Enrollment was for up to forty-five IL-2-naive patients.
In the amended phase of this study, up to 60 patients with HIV infection and CD4 counts equal to or greater than 350 will be studied to determine the ability of prednisone to ameliorate IL-2 related toxicity. Patients will be randomized to one of four groups: IL-2 alone; IL-2 plus prednisone; prednisone alone; no treatment. All four groups will be treated with a combination regimen of antiretrovirals to include at least one protease inhibitor. IL-2 will be dosed SQ at a starting dosage of 7.5 mlU bid x 5 days every 8 weeks, and prednisone (or placebo) will be dosed at 0.5 mg/kg/day during IL-2 cycles. Primary endpoints are frequency of IL-2 associated fatigue and fever, CD4 count changes, and viral load changes. Secondary endpoints include frequency of other IL-2 side effects, concomitant medication use, steroid associated side effects, cytokine changes during IL-2, and IL-2 total exposure in the IL-2 plus steroid vs. IL-2 plus placebo arms. The study period is one year with an optional extension period to follow.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infection
- Being tested
- IL-2 plus Anti-TNF or Thalidomide
- Keywords
- AIDS, Cytokines, Thalidomide, Monoclonal Antibody, Immunomodulator
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2 plus Anti-TNF or ThalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJun 1995
- Study completionJun 2002
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 Acquired Immunodeficiency SyndromeStudies 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
- Enrolment
- 85 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001475
- Sponsor's protocol ID
- 950133
- Other IDs
- 95-I-0133
- Status last verified
- Jun 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Davey RT Jr, Chaitt DG, Piscitelli SC, Wells M, Kovacs JA, Walker RE, Falloon J, Polis MA, Metcalf JA, Masur H, Fyfe G, Lane HC. Subcutaneous administration of interleukin-2 in human immunodeficiency virus type 1-infected persons. J Infect Dis. 1997 Apr;175(4):781-9. doi: 10.1086/513971.
PubMed 9086130Kovacs 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 8857018Andrieu JM, Lu W, Levy R. Sustained increases in CD4 cell counts in asymptomatic human immunodeficiency virus type 1-seropositive patients treated with prednisolone for 1 year. J Infect Dis. 1995 Mar;171(3):523-30. doi: 10.1093/infdis/171.3.523.
PubMed 7876597
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist in Patients With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00001475
- Acronym / sponsor ID
- 950133
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infection
- Keywords
- AIDS, Cytokines, Thalidomide, Monoclonal Antibody, Immunomodulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 1995
- Study completion
- Jun 2002
- First posted
- 4 Nov 1999 (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.
Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients in this study. Also, certain patients in this protocol may receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle.
To be eligible for home administration of IL-2, patients must:
- Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol, with at least two well-tolerated outpatient cycles at a stable dose.
- Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions, intravenous fluid replacement or dose reductions.
- Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles.
- Have a strong relationship with a private physician or health-care provider who has been involved in the patient's care and is willing to help supervise the patient's care during each home IL-2 cycle.
- Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff.
- Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle, providing the patient non-medical assistance and checking on his or her condition daily.
- Have reasonable access to emergency medical services and a nearby medical facility.
- Have proved reliable and consistent in using sterile technique, reconstituting IL-2 vials and administering subcutaneous IL-2 injections.
- Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their normal protocol participation.
- Have access to a home weight scale and be able to weigh themselves each day for safety monitoring.
Participants will receive IL-2 cycles on the same schedule they followed in their original protocol participation. They will be seen at the Clinical Center at regularly scheduled follow-up visits between cycles and for a medical evaluation and blood drawing before the start of each cycle to determine the safety of administering the cycle. During the home cycle, the patient's case manager or other team member will place monitoring telephone calls on days 2 and 4 of the cycle and again a week later. The timing and number of these calls may change depending on the findings of ongoing assessments of their usefulness. Patients will be required to notify the study team promptly of any complications or other problems that develop with therapy.
Detailed description
In the initial phase of this study, HIV-infected patients with CD4 counts between 200 and 500 were randomized to receive either IL-2 alone by continuous IV infusion for 5 days every 8 weeks, IL-2 plus anti-TNF antibody, or IL-2 plus thalidomide. The primary endpoints of this study are safety and tolerability of the IL-2/TNF inhibitor combination. Secondary endpoints will include changes in CD4 counts, frequency and severity of IL-2 related side effects, changes in serum TNF levels, and plasma viral load changes. The study period is one year, with an optional extension period to follow. Enrollment was for up to forty-five IL-2-naive patients.
In the amended phase of this study, up to 60 patients with HIV infection and CD4 counts equal to or greater than 350 will be studied to determine the ability of prednisone to ameliorate IL-2 related toxicity. Patients will be randomized to one of four groups: IL-2 alone; IL-2 plus prednisone; prednisone alone; no treatment. All four groups will be treated with a combination regimen of antiretrovirals to include at least one protease inhibitor. IL-2 will be dosed SQ at a starting dosage of 7.5 mlU bid x 5 days every 8 weeks, and prednisone (or placebo) will be dosed at 0.5 mg/kg/day during IL-2 cycles. Primary endpoints are frequency of IL-2 associated fatigue and fever, CD4 count changes, and viral load changes. Secondary endpoints include frequency of other IL-2 side effects, concomitant medication use, steroid associated side effects, cytokine changes during IL-2, and IL-2 total exposure in the IL-2 plus steroid vs. IL-2 plus placebo arms. The study period is one year with an optional extension period to follow.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| IL-2 plus Anti-TNF or Thalidomide | 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 4 Mar 2008.
- Background: PubMed 9086130Davey RT Jr, Chaitt DG, Piscitelli SC, Wells M, Kovacs JA, Walker RE, Falloon J, Polis MA, Metcalf JA, Masur H, Fyfe G, Lane HC. Subcutaneous administration of interleukin-2 in human immunodeficiency virus type 1-infected persons. J Infect Dis. 1997 Apr;175(4):781-9. doi: 10.1086/513971.
- 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 7876597Andrieu JM, Lu W, Levy R. Sustained increases in CD4 cell counts in asymptomatic human immunodeficiency virus type 1-seropositive patients treated with prednisolone for 1 year. J Infect Dis. 1995 Mar;171(3):523-30. doi: 10.1093/infdis/171.3.523.
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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 2 study testing IL-2 plus Anti-TNF or Thalidomide in people with Acquired Immunodeficiency Syndrome and HIV Infection, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 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 NCT00001475, 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 4 Mar 2008.