HIV InfectionPhase 3NCT00324103
Structured Treatment Interruptions in Chronic HIV Infection
A Phase 3 study testing Structured Treatment Interruptions in people with HIV Infection, run by Istituto Superiore di Sanità at 1 site in Italy.
Trial summary
In the last years Structured Treatment Interruptions (STI) have been proposed to reduce HAART-related toxicity and to increase patients' compliance. ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Structured Treatment Interruptions
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2001to Jun 2004
- Phase
- Phase 3
- 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
- first-line antiretroviral therapy (3 or 4 drugs) for 6 to 18 months (one previous therapy change for toxicity or non-compliance is allowed)
- HIV-RNA level below 400 copies/ml for at least 6 months;
- CD4+ count > 350 /mm3;
- pre-HAART CD4+ > 100/mm3
- no previous AIDS diagnosis.
Who cannot join
- Previous antiretroviral therapy with 1 or 2 drugs (except ARV prophylaxis in pregnancy)
- Pregnancy or breastfeeding
- Previous diagnosis of AIDS
- Grade 3 or 4 adverse event in the 15 days before enrolment
- Neoplasia
- Previous therapy with IL-2, interferon (in the last 2 years) or experimental therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiretroviral Treatment With Structured Treatment Interruptions (STI) Versus Continuous Antiretroviral Treatment in HIV+ Patients With Persistent Suppression of Viral Replication
In the last years Structured Treatment Interruptions (STI) have been proposed to reduce HAART-related toxicity and to increase patients' compliance. ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication. The two arms of the study will be compared in terms of immunological response (proportion of patients with CD4>500/mmc) at 2 years.
Read the detailed description
Patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen (Arm A) or to undergo structured treatment interruptions (STI) (Arm B) according to the following scheme: STIs of 1, 1, 2, 2 and 3 months each followed by a 3-month therapy period.
During STIs, therapy is resumed in the presence of an HIV-RNA rebound > 50,000 copies/ml or of a CD4+ T cell decline > 25% of the baseline count (> 35% for patients with CD4+ > 500/mm3 at randomization). After the first cycle, subsequent STIs are performed only if an HIV-RNA level < 400 copies/ml is reached after 2 months of therapy resumption.
At the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen.
Patients are seen at the clinical site every three months for arm A and monthly for arm B. On these occasions, blood samples are obtained for biochemical and viro-immunological assessments.
The toxicity grading scale of the AIDS Clinical Trial Group (ACTG) is used for the reporting of clinical and laboratory adverse events.
In arm B, plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension.
Patients will discontinue the study in case of : early therapy resumption for 2 consecutive times (only arm B patients); acute retroviral syndrome (only for arm B patients); AIDS-defining event; severe adverse event; pregnancy; non-compliance; patient' s request; physician's decision.
- Conditions
- HIV Infection
- Being tested
- Structured Treatment Interruptions
- Keywords
- HIV, Chronic Infection, Clinical Trial, Structured Treatment Interruption
- Medical subject headings
- HIV Infections, Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Treatment InterruptionsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with CD4+ cell count above 500/mm3 at the end of follow-up (2 years) in the two treatment arms.
Secondary outcomes (6)
occurrence of grade 3 or 4 adverse events (clinical and laboratory)
proportion of patients with HIV-RNA < 400 copies/ml at the end of follow-up
proportion of patients with CD4+ cell count > 350/mm3 at the end of follow-up
rate of virological failure
emergence of resistance
HIV-related events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startJun 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Istituto Superiore di Sanità
- Sponsor type
- University, hospital or other
- Investigators
- Stefano Vella, MD, Study chair, Istituto Superiore di Sanità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324103
- Sponsor's protocol ID
- ISS PART
- Status last verified
- Oct 2005
- First submitted
- 8 May 2006
- Last updated
- 10 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Treatment With Structured Treatment Interruptions (STI) Versus Continuous Antiretroviral Treatment in HIV+ Patients With Persistent Suppression of Viral Replication
- ClinicalTrials.gov ID
- NCT00324103
- Acronym / sponsor ID
- ISS PART
- Conditions
- HIV Infection
- Keywords
- HIV, Chronic Infection, Clinical Trial, Structured Treatment Interruption
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Istituto Superiore di SanitàUniversity, hospital or other
- Study start
- Jun 2001
- Study completion
- Jun 2004
- First posted
- 10 May 2006 (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.
In the last years Structured Treatment Interruptions (STI) have been proposed to reduce HAART-related toxicity and to increase patients' compliance. ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication. The two arms of the study will be compared in terms of immunological response (proportion of patients with CD4>500/mmc) at 2 years.
Detailed description
Patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen (Arm A) or to undergo structured treatment interruptions (STI) (Arm B) according to the following scheme: STIs of 1, 1, 2, 2 and 3 months each followed by a 3-month therapy period.
During STIs, therapy is resumed in the presence of an HIV-RNA rebound > 50,000 copies/ml or of a CD4+ T cell decline > 25% of the baseline count (> 35% for patients with CD4+ > 500/mm3 at randomization). After the first cycle, subsequent STIs are performed only if an HIV-RNA level < 400 copies/ml is reached after 2 months of therapy resumption.
At the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen.
Patients are seen at the clinical site every three months for arm A and monthly for arm B. On these occasions, blood samples are obtained for biochemical and viro-immunological assessments.
The toxicity grading scale of the AIDS Clinical Trial Group (ACTG) is used for the reporting of clinical and laboratory adverse events.
In arm B, plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension.
Patients will discontinue the study in case of : early therapy resumption for 2 consecutive times (only arm B patients); acute retroviral syndrome (only for arm B patients); AIDS-defining event; severe adverse event; pregnancy; non-compliance; patient' s request; physician's decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- first-line antiretroviral therapy (3 or 4 drugs) for 6 to 18 months (one previous therapy change for toxicity or non-compliance is allowed)
- HIV-RNA level below 400 copies/ml for at least 6 months;
- CD4+ count > 350 /mm3;
- pre-HAART CD4+ > 100/mm3
- no previous AIDS diagnosis.
Key exclusion criteria (6 listed)
- Previous antiretroviral therapy with 1 or 2 drugs (except ARV prophylaxis in pregnancy)
- Pregnancy or breastfeeding
- Previous diagnosis of AIDS
- Grade 3 or 4 adverse event in the 15 days before enrolment
- Neoplasia
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 |
|---|---|---|
| Structured Treatment Interruptions | Drug | – |
Primary outcome
proportion of patients with CD4+ cell count above 500/mm3 at the end of follow-up (2 years) in the two treatment arms.
6 secondary outcomes
occurrence of grade 3 or 4 adverse events (clinical and laboratory)
proportion of patients with HIV-RNA < 400 copies/ml at the end of follow-up
proportion of patients with CD4+ cell count > 350/mm3 at the end of follow-up
rate of virological failure
emergence of resistance
HIV-related events.
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 10 May 2006.
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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.
Stefano Vella, MD study chair
Istituto Superiore di Sanità
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Structured Treatment Interruptions in people with HIV Infection, run by Istituto Superiore di Sanità at 1 site in Italy.
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 10 May 2006. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
proportion of patients with CD4+ cell count above 500/mm3 at the end of follow-up (2 years) in the two treatment arms.. 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 May 2006.