HIV InfectionsPhase 2ILIADENCT00071890
Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Received Antiretroviral Tx
A Phase 2 study testing Interleukin 2, HAART and Treatment interruption in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
Trial summary
This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. 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, HAART and Treatment interruption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2003to Dec 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age greater than or equal to 18 years.
- HIV-1 infection confirmed by ELISA and Western Blot before screening.
- Category A or B HIV-1 infection.
- Antiretroviral treatment:
- started at least 12 months prior to screening visit;
- stable and continuous for at least 12 weeks prior to screening visit;
Show all 14Show fewer
- modified no more than once for virologic failure.
- IL-2 naive
- CD-4(+) T-lymphocyte count greater than or equal to 500 cells/mm(3) in the twelve weeks prior to screening (historical) and at screening.
- Nadir CD4(+) T-lymphocyte count greater than or equal to 200 cells/mm(3) prior to screening visit (that is, no measurement whose values may be less than 200/mm(3) since diagnosis of the HIV infection.
- Plasma HIV RNA less than 50 copies/ml in the 12 weeks preceding screening (historical, less than limit of detection if different method and/or cut off used) and at screening.
- For women of child-bearing age: use of effective contraception (hormonal such as birth control pill or injections, intrauterine device, surgical sterilization and/or mechanical barrier methods such as diaphragm or condoms); for all participants agreement to fully comply with prevention of transmission recommendations during periods of viremia if sexually active (latex condoms with or without additional barrier methods).
- Desire to interrupt antiretroviral therapy.
- Ability to sign informed consent (no later than W-2).
Who cannot join
- Previous treatment with IL-2.
- Combined treatment with interferon, other interleukins, anti-HIV vaccines, systemic (not topical or inhaled) corticosteroids and hydroxyurea within the previous 12 weeks.
- Diagnosis of AIDS.
- Acute infection in the 14 days preceding inclusion.
- Pregnant, lactating woman desiring conception or not using contraception.
- Hemoglobin less than 10 g/dl; neutrophils less than 1,000/mm(3); platelets less than 50,000/mm(3); creatinine greater than 1.5 times the upper limit of normal (N); bilirubin greater than 3N; AST or ALT greater than 3 N.
Show all 13Show fewer
- Progressive disease of malignant, psychiatric, cardiac, pulmonary, thyroid, renal or neurological (peripheral or central) origin or severe disorders of hemostasis.
- Severe uncontrolled hypertension.
- Previous or progressive pathology contraindicating the administration of IL-2.
- History of extensive psoriasis, Crohn's disease or auto-immune disease involving severe complications.
- HTLV-1 infection (ELISA positive).
- Hepatitis B virus co-infection treated with lamivudine or tenofovir or adefovir.
- Since atazanavir use can be associated with higher bilirubin levels (mostly indirect) in the absence of clinical consequences, subjects on atazanavir with bilirubin up to 4.5 times N may be allowed to participate if the levels have been stable and after approval by the PI or the PI designated covering physician.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Anti-Retroviral TX in HIV Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm(3) Who Have Received Anti-Retroviral TX
This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of ARV, and the effect on quality of life.
The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients. But when used long term, those medications have been associated with great toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes, or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus to gain entry into its host. The CD4 count increases immediately in response to ARV, giving an estimate of the state of a patient's immune system. Thus, it is a strong marker of the immediate risk of an opportunistic infection, one that takes advantage of a person's weakened immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8 weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV.
Read more
Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection, may be eligible for this study.
Participants will undergo the following procedures and tests:
- Physical examination.
- Blood tests to measure blood lipids (fats), sugar, complete blood count including platelets, and chemistries.
- Assessment of fat distribution.
- Questionnaire about quality of life.
In addition, those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24. They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter. The study will continue into 120 weeks. Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts. Every 24 weeks, they will be asked to answer a questionnaire about their quality of life. Blood tests and other measurements will also be done as follow-up.
Read the detailed description
The use of antiretroviral (ARV) medications has greatly improved morbidity and mortality of HIV-infected patients but long-term use of these agents has been associated with significant toxicities and medication fatigue that can lead to problems with adherence and eventual development of virologic resistance. The spectrum of ARV toxicities is broad including the development of lipodystrophy syndrome with lipid abnormalities and glucose intolerance or diabetes, while increasing evidence suggests an increased risk of cardiovascular complications in ARV-treated HIV-infected individuals. Current PHHS treatment guidelines recommend deferring ARV treatment initiation in asymptomatic HIV-infected individuals with CD4 count greater than or equal to 350 cells/micro liter, and treatment initiation after the CD4 count is less than 350 cells/micro liter. Several patients who started antiretroviral therapy at higher CD4 counts (based on older treatment initiation guidelines) or have experienced significant immunologic reconstitution after ARV initiation, elect to interrupt antiretroviral therapy until their CD4 count reaches the level of current recommendations for therapy initiation (less than 350 cells/micro liter).
Studies to date suggest that baseline and nadir CD4 count are the best predictors of a longer duration of treatment interruption that may be more beneficial with respect to reversal or delay of long-term ARV-associated toxicity and improved quality of life. It is known that intermittent cycles of IL-2 administration can lead to expansion of the CD4 pool and prolong survival of CD4 T cells. In this study the hypothesis tested is that IL-2 given prior to ARV treatment interruption could significantly prolong the period of ARV treatment interruption with preservation of CD4 counts above 350 cells/micro liter, and that this prolongation will be beneficial with respect to antiretroviral related toxicity and quality of life.
The study will have two parts: during the first part (24 weeks) patients will be randomized 1:1 to either receive three cycles or IL-2 with their ARV therapy or ARV therapy alone. In the second part (week 24 to week 120), all participants will interrupt therapy and restart when CD4 is less than 350 cells/micro liter. The main comparison will be at week 72, when the proportion of patients from the two groups who remain off drugs and have a CD4 greater than 350 cells/micro liter will be compared. At regular intervals (every 24 weeks) lipodystrophy measurements and quality of life questionnaires will be evaluated.
- Conditions
- HIV Infections
- Being tested
- Interleukin 2, HAART, Treatment interruption
- Keywords
- Interleukin 2, Treatment Interruption, HIV
- 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 2Drug
Also called Interleukin-2, IL-2, aldesleukin
Three cycles of IL-2 (6 MUI bid during 5 days = one cycle)
HAARTDrug
Also called Antiretroviral treatment
HAART from week 0 to week 24
Treatment interruptionDrug
HAART is interrupted from week 24 in both arms
| Study group | Role | What they receive |
|---|---|---|
| Interleukin 2 group | Active comparator | HAART (standard of care) and three cycles of IL-2 Receives: Drug: Interleukin 2; Drug: HAART; Drug: Treatment interruption |
| Control group | Active comparator | HAART alone Receives: Drug: HAART; Drug: Treatment interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Without Failure of Strategy From Week 0 to Week 72
A failure of strategy is defined on the first occurrence of one of the following events:
- CD4 T-lymphocyte count becomes < 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks
- Planned interruption of therapy at Wk24 cannot be done for any reason;
- Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason
- Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I)
- Subject expires between Wk0 and Wk72 (whatever the cause of death)
- Subject is lost to follow up
Measured: week 72
Secondary outcomes (2)
Changes in CD4 Counts at Week 72
Measured: week 72
AIDS Events
AIDS defined events according to CDC classification
Measured: Overall study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2003 (estimated)
- Study startOct 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- ANRS, Emerging Infectious Diseases
- Investigators
- Yves Lévy, PHD, Study chair, CHU Henri Mondor Créteil, FRANCEIrini Sereti, MD, Study chair, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071890
- Sponsor's protocol ID
- 040018
- Other IDs
- 04-I-0018, ANRS 118 ILIADE
- Acronym
- ILIADE
- Status last verified
- Sep 2010
- First submitted
- 3 Nov 2003
- Last updated
- 5 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Arno A, Ruiz L, Juan M, Jou A, Balague M, Zayat MK, Marfil S, Martinez-Picado J, Martinez MA, Romeu J, Pujol-Borrell R, Lane C, Clotet B. Efficacy of low-dose subcutaneous interleukin-2 to treat advanced human immunodeficiency virus type 1 in persons with </=250/microL CD4 T cells and undetectable plasma virus load. J Infect Dis. 1999 Jul;180(1):56-60. doi: 10.1086/314831.
PubMed 10353861Carr A, Emery S, Lloyd A, Hoy J, Garsia R, French M, Stewart G, Fyfe G, Cooper DA. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group. J Infect Dis. 1998 Oct;178(4):992-9. doi: 10.1086/515653.
PubMed 9806026Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000 Oct 21;356(9239):1423-30. doi: 10.1016/S0140-6736(00)02854-3.
PubMed 11052597Alexandre M, Prague M, Lhomme E, Lelievre JD, Wittkop L, Richert L, Levy Y, Thiebaut R. Definition of Virological Endpoints Improving the Design of HIV Cure Strategies Using Analytical Antiretroviral Treatment Interruption. Clin Infect Dis. 2024 Dec 17;79(6):1447-1457. doi: 10.1093/cid/ciae235.
PubMed 38819800
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Anti-Retroviral TX in HIV Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm(3) Who Have Received Anti-Retroviral TX
- ClinicalTrials.gov ID
- NCT00071890
- Acronym / sponsor ID
- ILIADE / 040018
- Conditions
- HIV Infections
- Keywords
- Interleukin 2, Treatment Interruption, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- ANRS, Emerging Infectious Diseases
- Study start
- Oct 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Nov 2003 (estimated)
- Results
- Posted 5 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of ARV, and the effect on quality of life.
The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients. But when used long term, those medications have been associated with great toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes, or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus to gain entry into its host. The CD4 count increases immediately in response to ARV, giving an estimate of the state of a patient's immune system. Thus, it is a strong marker of the immediate risk of an opportunistic infection, one that takes advantage of a person's weakened immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8 weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV.
Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection, may be eligible for this study.
Participants will undergo the following procedures and tests:
- Physical examination.
- Blood tests to measure blood lipids (fats), sugar, complete blood count including platelets, and chemistries.
- Assessment of fat distribution.
- Questionnaire about quality of life.
In addition, those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24. They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter. The study will continue into 120 weeks. Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts. Every 24 weeks, they will be asked to answer a questionnaire about their quality of life. Blood tests and other measurements will also be done as follow-up.
Detailed description
The use of antiretroviral (ARV) medications has greatly improved morbidity and mortality of HIV-infected patients but long-term use of these agents has been associated with significant toxicities and medication fatigue that can lead to problems with adherence and eventual development of virologic resistance. The spectrum of ARV toxicities is broad including the development of lipodystrophy syndrome with lipid abnormalities and glucose intolerance or diabetes, while increasing evidence suggests an increased risk of cardiovascular complications in ARV-treated HIV-infected individuals. Current PHHS treatment guidelines recommend deferring ARV treatment initiation in asymptomatic HIV-infected individuals with CD4 count greater than or equal to 350 cells/micro liter, and treatment initiation after the CD4 count is less than 350 cells/micro liter. Several patients who started antiretroviral therapy at higher CD4 counts (based on older treatment initiation guidelines) or have experienced significant immunologic reconstitution after ARV initiation, elect to interrupt antiretroviral therapy until their CD4 count reaches the level of current recommendations for therapy initiation (less than 350 cells/micro liter).
Studies to date suggest that baseline and nadir CD4 count are the best predictors of a longer duration of treatment interruption that may be more beneficial with respect to reversal or delay of long-term ARV-associated toxicity and improved quality of life. It is known that intermittent cycles of IL-2 administration can lead to expansion of the CD4 pool and prolong survival of CD4 T cells. In this study the hypothesis tested is that IL-2 given prior to ARV treatment interruption could significantly prolong the period of ARV treatment interruption with preservation of CD4 counts above 350 cells/micro liter, and that this prolongation will be beneficial with respect to antiretroviral related toxicity and quality of life.
The study will have two parts: during the first part (24 weeks) patients will be randomized 1:1 to either receive three cycles or IL-2 with their ARV therapy or ARV therapy alone. In the second part (week 24 to week 120), all participants will interrupt therapy and restart when CD4 is less than 350 cells/micro liter. The main comparison will be at week 72, when the proportion of patients from the two groups who remain off drugs and have a CD4 greater than 350 cells/micro liter will be compared. At regular intervals (every 24 weeks) lipodystrophy measurements and quality of life questionnaires will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interleukin 2 group | Active comparator | Drug: Interleukin 2, Drug: HAART, Drug: Treatment interruptionHAART (standard of care) and three cycles of IL-2 |
| Control group | Active comparator | Drug: HAART, Drug: Treatment interruptionHAART alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age greater than or equal to 18 years.
- HIV-1 infection confirmed by ELISA and Western Blot before screening.
- Category A or B HIV-1 infection.
- started at least 12 months prior to screening visit;
- stable and continuous for at least 12 weeks prior to screening visit;
Key exclusion criteria (13 listed)
- Previous treatment with IL-2.
- Combined treatment with interferon, other interleukins, anti-HIV vaccines, systemic (not topical or inhaled) corticosteroids and hydroxyurea within the previous 12 weeks.
- Diagnosis of AIDS.
- Acute infection in the 14 days preceding inclusion.
- Pregnant, lactating woman desiring conception or not using contraception.
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 2Also: Interleukin-2, IL-2, aldesleukinThree cycles of IL-2 (6 MUI bid during 5 days = one cycle) | Drug | Interleukin 2 group |
| HAARTAlso: Antiretroviral treatmentHAART from week 0 to week 24 | Drug | Control group, Interleukin 2 group |
| Treatment interruptionHAART is interrupted from week 24 in both arms | Drug | Control group, Interleukin 2 group |
Primary outcome
Proportion of Patients Without Failure of Strategy From Week 0 to Week 72
Time frame: week 72
A failure of strategy is defined on the first occurrence of one of the following events: * CD4 T-lymphocyte count becomes < 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks * Planned interruption of therapy at Wk24 cannot be done for any reason; * Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason * Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I) * Subject expires between Wk0 and Wk72 (whatever the cause of death) * Subject is lost to follow up
2 secondary outcomes
Changes in CD4 Counts at Week 72
Time frame: week 72
AIDS Events
Time frame: Overall study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10353861Arno A, Ruiz L, Juan M, Jou A, Balague M, Zayat MK, Marfil S, Martinez-Picado J, Martinez MA, Romeu J, Pujol-Borrell R, Lane C, Clotet B. Efficacy of low-dose subcutaneous interleukin-2 to treat advanced human immunodeficiency virus type 1 in persons with </=250/microL CD4 T cells and undetectable plasma virus load. J Infect Dis. 1999 Jul;180(1):56-60. doi: 10.1086/314831.
- Background: PubMed 9806026Carr A, Emery S, Lloyd A, Hoy J, Garsia R, French M, Stewart G, Fyfe G, Cooper DA. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group. J Infect Dis. 1998 Oct;178(4):992-9. doi: 10.1086/515653.
- Background: PubMed 11052597Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000 Oct 21;356(9239):1423-30. doi: 10.1016/S0140-6736(00)02854-3.
- Derived from this study: PubMed 38819800Alexandre M, Prague M, Lhomme E, Lelievre JD, Wittkop L, Richert L, Levy Y, Thiebaut R. Definition of Virological Endpoints Improving the Design of HIV Cure Strategies Using Analytical Antiretroviral Treatment Interruption. Clin Infect Dis. 2024 Dec 17;79(6):1447-1457. doi: 10.1093/cid/ciae235.
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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.
Yves Lévy, PHD study chair
CHU Henri Mondor Créteil, FRANCE
Irini Sereti, MD study chair
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interleukin 2, HAART and Treatment interruption in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
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 14 inclusion and 13 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 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Proportion of Patients Without Failure of Strategy From Week 0 to Week 72 (time frame: week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071890, 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 5 Oct 2010.