Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART (ANRS 106 Window Trial)

Conditions
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HIV Infections

Intervention / Treatment
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* Procedure: Intermittent antiretroviral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intermittent antiretroviral therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infections