HIV InfectionsNCT01293513
Structured Treatment Interruption (STI) in Acute/Primary HIV
A study testing Gradual anti-HIV treatment interruption in people with HIV Infections, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has dramatically altered the course of HIV/AIDS, true cure is still unattainable and patients are required to take these medications for the rest of their lives. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Gradual anti-HIV treatment interruption
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Acute HIV infection, where the time from infection to seroconversion is from 6 to 12 weeks
- Patients with Primary HIV infection, where the time from appearance of HIV antibodies seroconversion until the setpoint is less than 6 months
- Post menopausal females or potentially fertile women who agree either to refrain from sexual relations or to use contraceptive devices
- Patients who are willing to participate and who understand the trial, can read and sign the agreement form prior to entering the study
Who cannot join
- Patients suffering from serious disease, including hepatic or renal insufficiency and following organ transplantation
- Pregnant females or potentially fertile women who are unwilling to refrain from sexual relations or to use contraceptive devices
- Patients requiring chemotherapy or radiotherapy up till six months before entering the trial
About this study
Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has dramatically altered the course of HIV/AIDS, true cure is still unattainable and patients are required to take these medications for the rest of their lives. As is well known, the prolonged use of such agents is associated with serious, sometimes life-threatening side effects, metabolic disturbances such as diabetes and an increased incidence of myocardial infarction.
In 1999, a patient with acute HIV infection was treated soon after diagnosis ("Berlin patient"). However because of intercurrent conditions, treatment was interrupted on two occasions. After the third introduction of therapy, treatment was terminated (arbitrarily) and the patient was found to have undetectable virus throughout a follow up of approximately 18 months. The possible explanation of this phenomenon was autovaccination. Other workers have tried Structured Treatment Interruption (STI) in Acute/Primary HIV Infection with controversial results, possibly because there were too few cycles of treatment interruption.
Read more
In a patient treated in our center for Acute HIV infection, after initial HAART therapy, he underwent gradually increasing interruptions of treatment from 1 to 7 weeks. After complete cessation of treatment, the patient was followed for 3 years, where CD4 levels were normal, CD4/CD8 ratio remained above 1 and the viral load was undetectable.
Our plan is to study patients with Acute/Primary HIV Infection, who have been treated with HAART for at least one year. Once they have been shown to have undetectable virus (less than 40 copies HIV RNA per milliliter) and CD4 above 500 per microliter with a CD4/CD8 above 1, they can be enrolled in the STI study.
The study will comprise 6 groups of 4 cycles of treatment/interruption with an increasing duration treatment interruptions alternating with treatment intervals over a 33 month period. Altogether there will be 24 treatment interruptions, lasting from 1 week to 6 weeks. During this time the patients will be regularly monitored for clinical events and laboratory parameters.
The purpose of the study is to determine whether patients with acute/primary HIV infection undergoing graded STI can achieve a normal immune status and undetectable viral load on a long-term basis.
- Conditions
- HIV Infections
- Being tested
- Gradual anti-HIV treatment interruption
- Keywords
- Only patients with Acute or Primary HIV infection will be studied
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual anti-HIV treatment interruptionOther
Also called STI (Structured treatment interruption)
Gradual interruption of anti-HIV treatment: the interruption initially for a week, up to six weeks' interruption, and continuing anti-HIV treatment for two weeks between successive interruptions
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 Cells normal value and Viral load undetectable (<50 per ml)
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293513
- Sponsor's protocol ID
- TASMC-10-IY-0190-10-TLV-CTIL
- Status last verified
- Feb 2011
- First submitted
- 8 Feb 2011
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Treatment Interruption (STI) in Acute/Primary HIV
- ClinicalTrials.gov ID
- NCT01293513
- Acronym / sponsor ID
- TASMC-10-IY-0190-10-TLV-CTIL
- Conditions
- HIV Infections
- Keywords
- Only patients with Acute or Primary HIV infection will be studied
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2011
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 10 Feb 2011 (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.
Although the introduction of Highly Active Anti-Retroviral Therapy - HAART - has dramatically altered the course of HIV/AIDS, true cure is still unattainable and patients are required to take these medications for the rest of their lives. As is well known, the prolonged use of such agents is associated with serious, sometimes life-threatening side effects, metabolic disturbances such as diabetes and an increased incidence of myocardial infarction.
In 1999, a patient with acute HIV infection was treated soon after diagnosis ("Berlin patient"). However because of intercurrent conditions, treatment was interrupted on two occasions. After the third introduction of therapy, treatment was terminated (arbitrarily) and the patient was found to have undetectable virus throughout a follow up of approximately 18 months. The possible explanation of this phenomenon was autovaccination. Other workers have tried Structured Treatment Interruption (STI) in Acute/Primary HIV Infection with controversial results, possibly because there were too few cycles of treatment interruption.
In a patient treated in our center for Acute HIV infection, after initial HAART therapy, he underwent gradually increasing interruptions of treatment from 1 to 7 weeks. After complete cessation of treatment, the patient was followed for 3 years, where CD4 levels were normal, CD4/CD8 ratio remained above 1 and the viral load was undetectable.
Our plan is to study patients with Acute/Primary HIV Infection, who have been treated with HAART for at least one year. Once they have been shown to have undetectable virus (less than 40 copies HIV RNA per milliliter) and CD4 above 500 per microliter with a CD4/CD8 above 1, they can be enrolled in the STI study.
The study will comprise 6 groups of 4 cycles of treatment/interruption with an increasing duration treatment interruptions alternating with treatment intervals over a 33 month period. Altogether there will be 24 treatment interruptions, lasting from 1 week to 6 weeks. During this time the patients will be regularly monitored for clinical events and laboratory parameters.
The purpose of the study is to determine whether patients with acute/primary HIV infection undergoing graded STI can achieve a normal immune status and undetectable viral load on a long-term basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with Acute HIV infection, where the time from infection to seroconversion is from 6 to 12 weeks
- Patients with Primary HIV infection, where the time from appearance of HIV antibodies seroconversion until the setpoint is less than 6 months
- Post menopausal females or potentially fertile women who agree either to refrain from sexual relations or to use contraceptive devices
- Patients who are willing to participate and who understand the trial, can read and sign the agreement form prior to entering the study
Key exclusion criteria (3 listed)
- Patients suffering from serious disease, including hepatic or renal insufficiency and following organ transplantation
- Pregnant females or potentially fertile women who are unwilling to refrain from sexual relations or to use contraceptive devices
- Patients requiring chemotherapy or radiotherapy up till six months before entering the trial
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 |
|---|---|---|
| Gradual anti-HIV treatment interruptionAlso: STI (Structured treatment interruption)Gradual interruption of anti-HIV treatment: the interruption initially for a week, up to six weeks' interruption, and continuing anti-HIV treatment for two weeks between successive interruptions | Other | – |
Primary outcome
CD4 Cells normal value and Viral load undetectable (<50 per ml)
Time frame: 33 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual anti-HIV treatment interruption in people with HIV Infections, run by Tel-Aviv Sourasky Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
CD4 Cells normal value and Viral load undetectable (<50 per ml) (time frame: 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2011; AzTrials last refreshed its copy on 30 Oct 2026.