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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00122551
• Other study ID #: ANRS 106 Window
• Status: Terminated
• Phase: Phase 3
• First received: July 19, 2005
• Last updated: July 28, 2005
• Start date: December 2001
• Est. completion date: April 2005

Study information

• Verified date: July 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• Intermittent antiretroviral therapy

Locations

Country	Name	City	State
France	Service des Maladies Infectieuses	Paris
France	Service des Maladies Infectieuses et Tropicales Hopital Purpan	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study
Secondary	1993 Centers for Disease Control (CDC) classification of HIV infection B or C events
Secondary	Proportions of patients with CD4 count over 450/µl at week 96
Secondary	Proportions of patients with plasma HIV load over 400 and 1000/ml thresholds
Secondary	Plasma and peripheral blood mononuclear cells (PBMC) HIV resistance patterns
Secondary	Proportions of patients withdrawing initial treatment strategy
Secondary	Assessment of lipodystrophy and metabolic abnormalities
Secondary	Antiretroviral therapy (ARTs) adherence assessment
Secondary	Quality of life assessment
Secondary	Cost impact of the strategies