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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Procedure: Intermittent antiretroviral therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART (ANRS 106 Window Trial)

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: December 2001
Estimated Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122551

Locations
France
Service des Maladies Infectieuses
Paris, France, 75010
Service des Maladies Infectieuses et Tropicales Hopital Purpan
Toulouse Cedex 9, France, 31059
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Bruno Marchou, MD Service des Maladies Infectieuses et Tropicales Hopital Purpan Toulouse
Study Chair: Jean Pierre Aboulker, MD Inserm SC10
  More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00122551     History of Changes
Other Study ID Numbers: ANRS 106 Window
Study First Received: July 19, 2005
Last Updated: July 28, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014