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Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120783
First Posted: July 19, 2005
Last Update Posted: January 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
July 12, 2005
July 19, 2005
January 18, 2007
February 2002
Not Provided
Decrease over 25% in CD4 counts (immunological failure–IF), or increase over 0.7 log in plasma HIV RNA (virological failure–VF) at two consecutive monthly visits during the 24-week study
Same as current
Complete list of historical versions of study NCT00120783 on ClinicalTrials.gov Archive Site
  • Development of an HIV-1-related AIDS defining event
  • Death
  • Change in CD4 cell count between baseline and week 24
  • Change in plasma HIV-RNA level between baseline and week 4, week 8, week 12 and week 24
  • Change in genotypic and phenotypic resistance between baseline and week 2
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance
Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial.
This study investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses.

In patients with HIV multidrug resistance, maintaining a failing full-dose HAART regimen usually results in significant drug toxicity and in continued accumulation of resistance mutations that can preclude future therapeutic options. In contrast, treatment interruption provokes the reemergence of wild-type virus with full replicative and pathogenic capacity. The researchers investigated whether a calibrated reduction in drug pressure could stabilize the evolution and the pathogenic potential of resistant virus.

A prospective pilot study was conducted in patients receiving protease inhibitor-based HAART with a resistance genotype predicting less than two active drugs according to the 2002 ANRS algorithm, CD4 counts over or equal to 100/mm3 and plasma HIV RNA below or equal to 5 log/ml. The treatment was low-dose IDV/RTV (200/100 BID) and 3TC 150mg BID. IDV doses were adjusted at week 4 to ensure a Cmin of 250+/-100ng/ml, which, based on a panel of multi-PI resistant viruses, was calculated to yield an inhibitory quotient (Cmin/IC50) of 0.50. Primary end-points were over 25% decrease in CD4 counts (immunological failure–IF), or over 0.7 log increase in plasma HIV RNA (virological failure–VF) at two consecutive monthly visits during the 24-week study. Inclusions were to stop when the total number of failures (VF+IF) reached 7

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir
  • Drug: Lamivudine
  • Drug: Ritonavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
August 2003
Not Provided

Inclusion Criteria:

  • HIV-1 infection confirmed by Western Blot
  • Karnofsky score over or equal to 70
  • CD4 over or equal to 200/mm3
  • Plasma viral RNA over or equal to 10 000 copies/ml and below 100 000 copies/ml.
  • Stability of plasma viral load and CD4-during the last 3 months
  • failure of two antiretroviral regimens with 2 PI and one NNRTI
  • New efficacy drug on genotype not available
  • Treatment on hand with 3 antiretroviral drugs with one PI since 3 months.
  • Written inform consent
  • Pregnancy

Exclusion Criteria:

  • Hemoglobin below 8g/dL
  • Neutrophils below 750/mm3
  • ASAT, ALAT over 5N
  • Hepatic insufficiency (prothrombin below 50%)
  • Acute opportunistic infection
  • Immunotherapy
  • Treatment with active antiretroviral regimen
  • Treatment with enzyme inductor
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00120783
ANRS 109 VISTA
Not Provided
Not Provided
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Odile Launay, MD Hopital Avicenne,Bobigny, Service de Médecine Interne
Study Chair: Dominique Costagliola Inserm U720
French National Agency for Research on AIDS and Viral Hepatitis
January 2007

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