HIV InfectionsPhase 3NCT00122551
Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)
A Phase 3 study testing Intermittent antiretroviral therapy in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 sites in France.
Trial summary
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. 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?
- Intermittent antiretroviral therapy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2001to Apr 2005
- 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
- HIV-1 infection
- CD4 cell count over 450/µl for at least 6 months prior to screening
- Plasma HIV1-RNA below 200 cop/ml for at least 6 months prior to screening
- Stable and well tolerated ART for at least 6 months prior to screening
- Acceptable methods of contraception
- Patient able to comply with the protocol
- Informed consent signed prior to (or at) screening
Who cannot join
- CD4 nadir below 100/µl
- Abacavir or nevirapine in the current ART
- Hepatitis B with 3-TC, adefovir or tenofovir current therapy
- Current or upcoming treatment with interferon for hepatitis B or C
- History of AIDS-defining event in the 18 months prior to screening
- Pregnancy or breast feeding
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service des Maladies Infectieuses
Paris, 75010
Service des Maladies Infectieuses et Tropicales Hopital Purpan
Toulouse, 31059
About this study
Official title: A Prospective, Randomized, Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART (ANRS 106 Window Trial)
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection.
Read the detailed description
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern.
The purpose of this study is to compare an intermittent therapy (IT) strategy (8 weeks off / 8 weeks on) to a continuous treatment (CT) in patients with chronic and well controlled HIV-1 infection (CD4 over 450/µl and plasma HIV1-RNA below 200 cp/ml) under HAART, over a 96-week study period.
The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300/µl. It will compare the proportions of and time to immunological failure (CD4 count below 300/µl confirmed by a retest 14 days later) in the IT and CT groups.
- Conditions
- HIV Infections
- Being tested
- Intermittent antiretroviral therapy
- Keywords
- HIV infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent antiretroviral therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study
Secondary outcomes (9)
1993 Centers for Disease Control (CDC) classification of HIV infection B or C events
Proportions of patients with CD4 count over 450/µl at week 96
Proportions of patients with plasma HIV load over 400 and 1000/ml thresholds
Plasma and peripheral blood mononuclear cells (PBMC) HIV resistance patterns
Proportions of patients withdrawing initial treatment strategy
Assessment of lipodystrophy and metabolic abnormalities
Antiretroviral therapy (ARTs) adherence assessment
Quality of life assessment
Cost impact of the strategies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startDec 2001
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Investigators
- Bruno Marchou, MD, Principal investigator, Service des Maladies Infectieuses et Tropicales Hopital Purpan ToulouseJean Pierre Aboulker, MD, Study chair, Inserm SC10
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122551
- Sponsor's protocol ID
- ANRS 106 Window
- Status last verified
- Jul 2005
- First submitted
- 19 Jul 2005
- Last updated
- 1 Aug 2005
- Results posted
- No
Publications
Delobel P, Saliou A, Nicot F, Dubois M, Trancart S, Tangre P, Aboulker JP, Taburet AM, Molina JM, Massip P, Marchou B, Izopet J; ANRS 106-Window Study Team. Minor HIV-1 variants with the K103N resistance mutation during intermittent efavirenz-containing antiretroviral therapy and virological failure. PLoS One. 2011;6(6):e21655. doi: 10.1371/journal.pone.0021655. Epub 2011 Jun 27.
PubMed 21738752Charreau I, Jeanblanc G, Tangre P, Boyer L, Saouzanet M, Marchou B, Molina JM, Aboulker JP, Durand-Zaleski I; ANRS 106 Study Group. Costs of intermittent versus continuous antiretroviral therapy in patients with controlled HIV infection: a substudy of the ANRS 106 Window Trial. J Acquir Immune Defic Syndr. 2008 Dec 1;49(4):416-21. doi: 10.1097/QAI.0b013e31818a657c.
PubMed 18931625
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART (ANRS 106 Window Trial)
- ClinicalTrials.gov ID
- NCT00122551
- Acronym / sponsor ID
- ANRS 106 Window
- Conditions
- HIV Infections
- Keywords
- HIV infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Dec 2001
- Study completion
- Apr 2005
- First posted
- 22 Jul 2005 (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 lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection.
Detailed description
Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern.
The purpose of this study is to compare an intermittent therapy (IT) strategy (8 weeks off / 8 weeks on) to a continuous treatment (CT) in patients with chronic and well controlled HIV-1 infection (CD4 over 450/µl and plasma HIV1-RNA below 200 cp/ml) under HAART, over a 96-week study period.
The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300/µl. It will compare the proportions of and time to immunological failure (CD4 count below 300/µl confirmed by a retest 14 days later) in the IT and CT groups.
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 (7 listed)
- HIV-1 infection
- CD4 cell count over 450/µl for at least 6 months prior to screening
- Plasma HIV1-RNA below 200 cop/ml for at least 6 months prior to screening
- Stable and well tolerated ART for at least 6 months prior to screening
- Acceptable methods of contraception
Key exclusion criteria (6 listed)
- CD4 nadir below 100/µl
- Abacavir or nevirapine in the current ART
- Hepatitis B with 3-TC, adefovir or tenofovir current therapy
- Current or upcoming treatment with interferon for hepatitis B or C
- History of AIDS-defining event in the 18 months prior to screening
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 |
|---|---|---|
| Intermittent antiretroviral therapy | Procedure or surgery | – |
Primary outcome
Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study
9 secondary outcomes
1993 Centers for Disease Control (CDC) classification of HIV infection B or C events
Proportions of patients with CD4 count over 450/µl at week 96
Proportions of patients with plasma HIV load over 400 and 1000/ml thresholds
Plasma and peripheral blood mononuclear cells (PBMC) HIV resistance patterns
Proportions of patients withdrawing initial treatment strategy
Assessment of lipodystrophy and metabolic abnormalities
Antiretroviral therapy (ARTs) adherence assessment
Quality of life assessment
Cost impact of the strategies
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2005.
- Derived from this study: PubMed 21738752Delobel P, Saliou A, Nicot F, Dubois M, Trancart S, Tangre P, Aboulker JP, Taburet AM, Molina JM, Massip P, Marchou B, Izopet J; ANRS 106-Window Study Team. Minor HIV-1 variants with the K103N resistance mutation during intermittent efavirenz-containing antiretroviral therapy and virological failure. PLoS One. 2011;6(6):e21655. doi: 10.1371/journal.pone.0021655. Epub 2011 Jun 27.
- Derived from this study: PubMed 18931625Charreau I, Jeanblanc G, Tangre P, Boyer L, Saouzanet M, Marchou B, Molina JM, Aboulker JP, Durand-Zaleski I; ANRS 106 Study Group. Costs of intermittent versus continuous antiretroviral therapy in patients with controlled HIV infection: a substudy of the ANRS 106 Window Trial. J Acquir Immune Defic Syndr. 2008 Dec 1;49(4):416-21. doi: 10.1097/QAI.0b013e31818a657c.
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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.
Bruno Marchou, MD principal investigator
Service des Maladies Infectieuses et Tropicales Hopital Purpan Toulouse
Jean Pierre Aboulker, MD study chair
Inserm SC10
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intermittent antiretroviral therapy in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 sites in France.
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 7 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: stopped early, as of the sponsor's last update on 1 Aug 2005. 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 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 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 was stopped early. 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?
Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study. 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 NCT00122551, which also lists 2 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 Aug 2005.