HIV InfectionsNCT00001116
A Study to Evaluate the Ability of TNFR:Fc to Decrease the Amount of IL-6 (Interleukin-6) and TNF-alpha (Tumor Necrosis Factor) in HIV-Infected Patients
A study testing Tumor Necrosis Factor soluble receptor-immunoadhesin complex in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can lower the amount of IL-6 in HIV-positive patients. This study will also examine the effect of TNFR:Fc on TNF-alpha. IL-6 and TNF-alpha are 2 substances produced by the immune system that may increase the rate of HIV replication. 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?
- Tumor Necrosis Factor soluble receptor-immunoadhesin complex
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Jun 2000
- 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
- You may be eligible for this study if you:
- Are HIV-positive.
- Are enrolled in ACTG 328.
- Agree to practice abstinence or use barrier methods of birth control during the study.
- Are at least 18 years old.
Who cannot join
- You will not be eligible for this study if you:
- Have any active opportunistic (HIV-associated) infections.
- Have any medical condition or psychological issue that would interfere with study requirements.
- Are pregnant or breast-feeding.
- Are receiving any experimental drug other than IL-2.
- Are receiving certain other medications.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Case CRS
Cleveland, Ohio, 44106
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
NY Univ. HIV/AIDS CRS
New York, New York, 10016
About this study
Official title: Effect of Recombinant Human Soluble Tumor Necrosis Factor Receptor (TNFR:Fc) on Interleukin-6 (IL-6), Tumor Necrosis Factor-Alpha (TNF-alpha) and Markers of Immune Activation in HIV-Infected Subjects
The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can lower the amount of IL-6 in HIV-positive patients. This study will also examine the effect of TNFR:Fc on TNF-alpha. IL-6 and TNF-alpha are 2 substances produced by the immune system that may increase the rate of HIV replication.
IL-6 and TNF-alpha are produced naturally by the body. High levels of TNF-alpha lead to increased IL-6 production and increased HIV replication, therefore helping the virus infect the body. HIV-positive patients who receive IL-2 (interleukin-2, a protein that helps the immune system fight infection) tend to have higher levels of IL-6 and TNF-alpha than patients not receiving IL-2. These increased levels may contribute to some of the flu-like symptoms related to IL-2 administration. TNFR:Fc can neutralize TNF-alpha to decrease the action of TNF-alpha and, in turn, decrease the amount of IL-6 in the body. TNFR:Fc may, therefore, have a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2 administration.
Read the detailed description
Both Interleukin-6 (IL-6) and Tumor necrosis factor-alpha (TNF-alpha) are substances naturally produced by the body's immune system. Evidence suggests that TNF-alpha production may be excessive or inappropriate in HIV-infected patients. Elevated TNF-alpha levels can result in increased IL-6 production and possibly increased HIV replication. TNFR:Fc is a modification of a natural substance that binds to TNF-alpha and neutralizes its activity. It is postulated that TNFR:Fc may result in decreased activity of TNF-alpha and lower IL-6 levels. HIV-infected patients who receive Interleukin-2 (IL-2) have been shown to have higher TNF-alpha and IL-6 levels than those who do not receive IL-2. It is thought that these higher levels of TNF-alpha and IL-6 may contribute to some of the flu-like symptoms experienced by patients receiving IL-2. By decreasing the amount of IL-6 in the body and by decreasing the action of TNF-alpha in the body, TNFR:Fc may have a role in the treatment of HIV disease or in alleviating some of the symptoms related to IL-2 administration.
Six patients from each of the 3 treatment arms of ACTG 328 (HAART alone, HAART plus intravenous (IV) rhIL-2, and HAART plus subcutaneous (SC) rhIL-2) who are about to be randomized to Step II of ACTG 328 may participate in this prospective, nested substudy. Patients randomized to the Interleukin-2 (IL-2) arms of ACTG 328 are pretreated with TNFR:Fc (administered by infusion over 30 minutes) at week 16 of ACTG 928 (Course 3, Week 28 of ACTG 328), just prior to initiation of IL-2. Those randomized to the highly active antiretroviral therapy (HAART) only arm of ACTG 328 receive treatment with TNFR:Fc at Week 16 of ACTG 928 (Week 28 of ACTG 328).
- Conditions
- HIV Infections
- Being tested
- Tumor Necrosis Factor soluble receptor-immunoadhesin complex
- Keywords
- Tumor Necrosis Factor, Interleukin-2, Immunity, Cellular, Antiviral Agents, Interleukin-6, Receptors, Tumor Necrosis Factor
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Necrosis Factor soluble receptor-immunoadhesin complexDrug
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 completionJun 2000
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 18 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sha B, Study chairValdez H, Study chairLanday A, Study chairLederman M, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001116
- Sponsor's protocol ID
- ACTG 928
- Other IDs
- 11498
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Lange CG, Valdez H, Medvik K, Asaad R, Lederman MM. CD4+ T-lymphocyte nadir and the effect of highly active antiretroviral therapy on phenotypic and functional immune restoration in HIV-1 infection. Clin Immunol. 2002 Feb;102(2):154-61. doi: 10.1006/clim.2001.5164.
PubMed 11846457Sha B, Valdez H, Landay A, Gelman R, Namkung A, Agosti J, Bancroft L, Mildvan D, Mitsuyasu R, Pollard R, Ogata-Arakaki D, Kilgo P, Estep S, Fox L, Lederman M. Effect of recombinant human soluble tumor necrosis factor receptor (TNFR, etanercept) on interleukin-6 (IL- 6), TNF-a, and markers of immune activation in HIV-infected subjects receiving interleukin-2 (IL-2). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 66)
Sha BE, Valdez H, Gelman RS, Landay AL, Agosti J, Mitsuyasu R, Pollard RB, Mildvan D, Namkung A, Ogata-Arakaki DM, Fox L, Estep S, Erice A, Kilgo P, Walker RE, Bancroft L, Lederman MM. Effect of etanercept (Enbrel) on interleukin 6, tumor necrosis factor alpha, and markers of immune activation in HIV-infected subjects receiving interleukin 2. AIDS Res Hum Retroviruses. 2002 Jun 10;18(9):661-5. doi: 10.1089/088922202760019365.
PubMed 12079562
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
- Effect of Recombinant Human Soluble Tumor Necrosis Factor Receptor (TNFR:Fc) on Interleukin-6 (IL-6), Tumor Necrosis Factor-Alpha (TNF-alpha) and Markers of Immune Activation in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00001116
- Acronym / sponsor ID
- ACTG 928
- Conditions
- HIV Infections
- Keywords
- Tumor Necrosis Factor, Interleukin-2, Immunity, Cellular, Antiviral Agents, Interleukin-6, Receptors, Tumor Necrosis Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jun 2000 (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.
The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can lower the amount of IL-6 in HIV-positive patients. This study will also examine the effect of TNFR:Fc on TNF-alpha. IL-6 and TNF-alpha are 2 substances produced by the immune system that may increase the rate of HIV replication.
IL-6 and TNF-alpha are produced naturally by the body. High levels of TNF-alpha lead to increased IL-6 production and increased HIV replication, therefore helping the virus infect the body. HIV-positive patients who receive IL-2 (interleukin-2, a protein that helps the immune system fight infection) tend to have higher levels of IL-6 and TNF-alpha than patients not receiving IL-2. These increased levels may contribute to some of the flu-like symptoms related to IL-2 administration. TNFR:Fc can neutralize TNF-alpha to decrease the action of TNF-alpha and, in turn, decrease the amount of IL-6 in the body. TNFR:Fc may, therefore, have a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2 administration.
Detailed description
Both Interleukin-6 (IL-6) and Tumor necrosis factor-alpha (TNF-alpha) are substances naturally produced by the body's immune system. Evidence suggests that TNF-alpha production may be excessive or inappropriate in HIV-infected patients. Elevated TNF-alpha levels can result in increased IL-6 production and possibly increased HIV replication. TNFR:Fc is a modification of a natural substance that binds to TNF-alpha and neutralizes its activity. It is postulated that TNFR:Fc may result in decreased activity of TNF-alpha and lower IL-6 levels. HIV-infected patients who receive Interleukin-2 (IL-2) have been shown to have higher TNF-alpha and IL-6 levels than those who do not receive IL-2. It is thought that these higher levels of TNF-alpha and IL-6 may contribute to some of the flu-like symptoms experienced by patients receiving IL-2. By decreasing the amount of IL-6 in the body and by decreasing the action of TNF-alpha in the body, TNFR:Fc may have a role in the treatment of HIV disease or in alleviating some of the symptoms related to IL-2 administration.
Six patients from each of the 3 treatment arms of ACTG 328 (HAART alone, HAART plus intravenous (IV) rhIL-2, and HAART plus subcutaneous (SC) rhIL-2) who are about to be randomized to Step II of ACTG 328 may participate in this prospective, nested substudy. Patients randomized to the Interleukin-2 (IL-2) arms of ACTG 328 are pretreated with TNFR:Fc (administered by infusion over 30 minutes) at week 16 of ACTG 928 (Course 3, Week 28 of ACTG 328), just prior to initiation of IL-2. Those randomized to the highly active antiretroviral therapy (HAART) only arm of ACTG 328 receive treatment with TNFR:Fc at Week 16 of ACTG 928 (Week 28 of ACTG 328).
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 (5 listed)
- Are HIV-positive.
- Are enrolled in ACTG 328.
- Agree to practice abstinence or use barrier methods of birth control during the study.
- Are at least 18 years old.
Key exclusion criteria (6 listed)
- Have any active opportunistic (HIV-associated) infections.
- Have any medical condition or psychological issue that would interfere with study requirements.
- Are pregnant or breast-feeding.
- Are receiving any experimental drug other than IL-2.
- Are receiving certain other medications.
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 |
|---|---|---|
| Tumor Necrosis Factor soluble receptor-immunoadhesin complex | 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 1 Nov 2021.
- Background: PubMed 11846457Lange CG, Valdez H, Medvik K, Asaad R, Lederman MM. CD4+ T-lymphocyte nadir and the effect of highly active antiretroviral therapy on phenotypic and functional immune restoration in HIV-1 infection. Clin Immunol. 2002 Feb;102(2):154-61. doi: 10.1006/clim.2001.5164.
- BackgroundSha B, Valdez H, Landay A, Gelman R, Namkung A, Agosti J, Bancroft L, Mildvan D, Mitsuyasu R, Pollard R, Ogata-Arakaki D, Kilgo P, Estep S, Fox L, Lederman M. Effect of recombinant human soluble tumor necrosis factor receptor (TNFR, etanercept) on interleukin-6 (IL- 6), TNF-a, and markers of immune activation in HIV-infected subjects receiving interleukin-2 (IL-2). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 66)
- Background: PubMed 12079562Sha BE, Valdez H, Gelman RS, Landay AL, Agosti J, Mitsuyasu R, Pollard RB, Mildvan D, Namkung A, Ogata-Arakaki DM, Fox L, Estep S, Erice A, Kilgo P, Walker RE, Bancroft L, Lederman MM. Effect of etanercept (Enbrel) on interleukin 6, tumor necrosis factor alpha, and markers of immune activation in HIV-infected subjects receiving interleukin 2. AIDS Res Hum Retroviruses. 2002 Jun 10;18(9):661-5. doi: 10.1089/088922202760019365.
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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.
Sha B study chair
Valdez H study chair
Landay A study chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Necrosis Factor soluble receptor-immunoadhesin complex in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 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 5 inclusion and 6 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 3 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.
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 NCT00001116, 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.