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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Terminated; Phase 3

Conditions: HIV Infections

Treatments: Procedure: Intermittent antiretroviral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00122551

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Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)