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

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.

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.

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