NCT00122551

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
Last Updated

August 1, 2005

Status Verified

July 1, 2005

First QC Date

July 19, 2005

Last Update Submit

July 28, 2005

Conditions

HIV Infections

Keywords

HIV infections

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Interventions

Intermittent antiretroviral therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service des Maladies Infectieuses

Paris, 75010, France

Location

Service des Maladies Infectieuses et Tropicales Hopital Purpan

Toulouse, 31059, France

Location

Related Publications (2)

  • Delobel P, Saliou A, Nicot F, Dubois M, Trancart S, Tangre P, Aboulker JP, Taburet AM, Molina JM, Massip P, Marchou B, Izopet J; ANRS 106-Window Study Team. Minor HIV-1 variants with the K103N resistance mutation during intermittent efavirenz-containing antiretroviral therapy and virological failure. PLoS One. 2011;6(6):e21655. doi: 10.1371/journal.pone.0021655. Epub 2011 Jun 27.

    PMID: 21738752DERIVED

  • Charreau I, Jeanblanc G, Tangre P, Boyer L, Saouzanet M, Marchou B, Molina JM, Aboulker JP, Durand-Zaleski I; ANRS 106 Study Group. Costs of intermittent versus continuous antiretroviral therapy in patients with controlled HIV infection: a substudy of the ANRS 106 Window Trial. J Acquir Immune Defic Syndr. 2008 Dec 1;49(4):416-21. doi: 10.1097/QAI.0b013e31818a657c.

    PMID: 18931625DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bruno Marchou, MD

    Service des Maladies Infectieuses et Tropicales Hopital Purpan Toulouse

    PRINCIPAL INVESTIGATOR

  • Jean Pierre Aboulker, MD

    Inserm SC10

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

December 1, 2001

Study Completion

April 1, 2005

Last Updated

August 1, 2005

Record last verified: 2005-07

Locations

FR(2)