HIVPhase 4PHI-IL2NCT02300623
Intermittent ART in Primary HIV Infection
A Phase 4 study testing Antiretroviral therapy plus Interleukin-2 and Antiretroviral therapy alone in people with HIV, run by Juan A. Arnaiz at 1 site in Spain.
Trial summary
Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Antiretroviral therapy plus Interleukin-2 and Antiretroviral therapy alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2000to Apr 2013
- Phase
- Phase 4
- 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
- PHI defined by detectable plasma viral load (PVL) or p24 antigen detection coupled with a negative or indeterminate LIA assay (according CDC criteria); negative HIV-1 EIA in the preceding 90 days or by a positive EIA and LIA assay with acute retroviral syndrome in the preceding 90 days of starting ART plus documented negative HIV-1 EIA within the previous year.
- ART started within 90 days from the HIV exposure and continuing in the same treatment at least 12 months before the inclusion, and they must have shown good virological and immunological responses, defined as undetectable PVL (<20 copies/mL in the last two controls) and CD4 more than 500 cells/mm3 with a CD4/CD8 ratio >1 in the last 8 months previous to enrolment
Who cannot join
- Infection of more than 90 days.
- Age under 18 years old.
- AIDS defining condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Follow-up of Patients Experiencing Structured Treatment Interruption (STI) With or Without Low Doses of Interleukin-2 During Primary HIV Infection (PHI)
Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. The investigators randomized patients with PHI, with a favourable immunological profile and well controlled on ART, to undergone structured treatment interruptions alone or with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up to nine years since final ART stop.
Read the detailed description
The study design included two phases. The first phase consisted in four STI of 8 weeks each (off-ART), separated by 16 weeks of treatment -or the time necessary to reach again to PVL <20 copies/mL- (on-ART). At the end of the 4th off-ART cycle (week 0) an interim evaluation was performed and the second phase initiated. During the second phase, the first 6 patients received ART until they reach PVL<20 copies/mL, discontinuing thereafter (final stop). The last 6 patients received ART and low doses of IL-2. ARV therapy was stopped after reaching PVL<20 copies/mL (final stop) and IL-2 after 6 months of treatment. IL-2 was prescribed at a dose of 750.000 UI/m2 daily and was self-administrated in all patients previous trained by a specialized nurse. ART was resumed in patient dropping CD4 cell count less than 350 cell/mm3 in two consecutive determinations or in patients who developed opportunistic infections. A long term follow up analysis was performed at 3, 6 and 9 years since the final stop. It included time to resume ART, clinical events, survival rate, CD4-CD8-CD4/CD8 ratio.
- Conditions
- HIV
- Being tested
- Antiretroviral therapy plus Interleukin-2, Antiretroviral therapy alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiretroviral therapy plus Interleukin-2Drug
Also called IL-2, Stavudine, Lamivudine, Indinavir
Daily s.c. IL-2: 750,000 UI/m2/day for 6 months
Antiretroviral therapy aloneDrug
Also called stavudine, Lamivudine, Indinavir
Standard antiretroviral therapy
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Antiretroviral therapy alone Receives: Drug: Antiretroviral therapy alone |
| Treatment | Experimental | Antiretroviral therapy plus Interleukin-2' Receives: Drug: Antiretroviral therapy plus Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of viral replication without ART.
Measured: 48 weeks
Secondary outcomes (1)
Time to resume ART.
Measured: 9 years after final stop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startMar 2000
- Primary completionApr 2013
- Study completionApr 2013
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 HIVStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
- Investigators
- Josep Maria Miró, MDPhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300623
- Sponsor's protocol ID
- PHI-IL2
- Acronym
- PHI-IL2
- Status last verified
- Nov 2014
- First submitted
- 18 Nov 2014
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sued O, Ambrosioni J, Nicolas D, Manzardo C, Aguero F, Claramonte X, Plana M, Tuset M, Pumarola T, Gallart T, Gatell JM, Miro JM. Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. Inflammatory, Virological and Immunological Outcomes. PLoS One. 2015 Jul 17;10(7):e0131651. doi: 10.1371/journal.pone.0131651. eCollection 2015.
PubMed 26186440
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Patients Experiencing Structured Treatment Interruption (STI) With or Without Low Doses of Interleukin-2 During Primary HIV Infection (PHI)
- ClinicalTrials.gov ID
- NCT02300623
- Acronym / sponsor ID
- PHI-IL2 / PHI-IL2
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Nov 2014 (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.
Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. The investigators randomized patients with PHI, with a favourable immunological profile and well controlled on ART, to undergone structured treatment interruptions alone or with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up to nine years since final ART stop.
Detailed description
The study design included two phases. The first phase consisted in four STI of 8 weeks each (off-ART), separated by 16 weeks of treatment -or the time necessary to reach again to PVL <20 copies/mL- (on-ART). At the end of the 4th off-ART cycle (week 0) an interim evaluation was performed and the second phase initiated. During the second phase, the first 6 patients received ART until they reach PVL<20 copies/mL, discontinuing thereafter (final stop). The last 6 patients received ART and low doses of IL-2. ARV therapy was stopped after reaching PVL<20 copies/mL (final stop) and IL-2 after 6 months of treatment. IL-2 was prescribed at a dose of 750.000 UI/m2 daily and was self-administrated in all patients previous trained by a specialized nurse. ART was resumed in patient dropping CD4 cell count less than 350 cell/mm3 in two consecutive determinations or in patients who developed opportunistic infections. A long term follow up analysis was performed at 3, 6 and 9 years since the final stop. It included time to resume ART, clinical events, survival rate, CD4-CD8-CD4/CD8 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Antiretroviral therapy aloneAntiretroviral therapy alone |
| Treatment | Experimental | Drug: Antiretroviral therapy plus Interleukin-2Antiretroviral therapy plus Interleukin-2' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PHI defined by detectable plasma viral load (PVL) or p24 antigen detection coupled with a negative or indeterminate LIA assay (according CDC criteria); negative HIV-1 EIA in the preceding 90 days or by a positive EIA and LIA assay with acute retroviral syndrome in the preceding 90 days of starting ART plus documented negative HIV-1 EIA within the previous year.
- ART started within 90 days from the HIV exposure and continuing in the same treatment at least 12 months before the inclusion, and they must have shown good virological and immunological responses, defined as undetectable PVL (<20 copies/mL in the last two controls) and CD4 more than 500 cells/mm3 with a CD4/CD8 ratio >1 in the last 8 months previous to enrolment
Key exclusion criteria (3 listed)
- Infection of more than 90 days.
- Age under 18 years old.
- AIDS defining condition
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 |
|---|---|---|
| Antiretroviral therapy plus Interleukin-2Also: IL-2, Stavudine, Lamivudine, IndinavirDaily s.c. IL-2: 750,000 UI/m2/day for 6 months | Drug | Treatment |
| Antiretroviral therapy aloneAlso: stavudine, Lamivudine, IndinavirStandard antiretroviral therapy | Drug | Control |
Primary outcome
Control of viral replication without ART.
Time frame: 48 weeks
1 secondary outcome
Time to resume ART.
Time frame: 9 years after final stop
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 25 Nov 2014.
- Derived from this study: PubMed 26186440Sued O, Ambrosioni J, Nicolas D, Manzardo C, Aguero F, Claramonte X, Plana M, Tuset M, Pumarola T, Gallart T, Gatell JM, Miro JM. Structured Treatment Interruptions and Low Doses of IL-2 in Patients with Primary HIV Infection. Inflammatory, Virological and Immunological Outcomes. PLoS One. 2015 Jul 17;10(7):e0131651. doi: 10.1371/journal.pone.0131651. eCollection 2015.
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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.
Josep Maria Miró, MDPhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antiretroviral therapy plus Interleukin-2 and Antiretroviral therapy alone in people with HIV, run by Juan A. Arnaiz at 1 site in Spain.
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 2 inclusion and 3 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 25 Nov 2014. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Control of viral replication without ART. (time frame: 48 weeks). 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 NCT02300623, 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 25 Nov 2014.