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

Phase 3

Terminated

• Conditions: HIV Infections

• Registration Number: NCT00122551
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief 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.

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 Timeline

• Study Start: 2001-12
• Study Completion: 2005-04
• Status Verified: 2005-07
• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-22
• Last Update Submitted: 2005-07-28
• Last Update Posted: 2005-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Service des Maladies Infectieuses et Tropicales Hopital Purpan; 🇫🇷 Toulouse Cedex 9, France

Service des Maladies Infectieuses; 🇫🇷 Paris, France