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

This study has been terminated.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122551
First received: July 19, 2005
Last updated: July 28, 2005
Last verified: July 2005

July 19, 2005
July 28, 2005
December 2001
Not Provided
Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study
immunological failure, defined by a CD4 cell below 300/µl confirmed by a retest 14 days later during the study
Complete list of historical versions of study NCT00122551 on ClinicalTrials.gov Archive Site
  • 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
  • 1993 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 PBMC HIV resistance patterns
  • Proportions of patients withdrawing initial treatment strategy
  • Assessment of lipodystrophy and metabolic abnormalities
  • ARTs adherence assessment
  • Quality of life assessment
  • Cost impact of the strategies
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Procedure: Intermittent antiretroviral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
April 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00122551
ANRS 106 Window
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Bruno Marchou, MD Service des Maladies Infectieuses et Tropicales Hopital Purpan Toulouse
Study Chair: Jean Pierre Aboulker, MD Inserm SC10
French National Agency for Research on AIDS and Viral Hepatitis
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP