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

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ClinicalTrials.gov Identifier: NCT00120783
Recruitment Status : Terminated
First Posted : July 19, 2005
Last Update Posted : January 18, 2007
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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Brief Summary:
This study investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Indinavir Drug: Lamivudine Drug: Ritonavir Phase 2

Detailed Description:

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial.
Study Start Date : February 2002
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Development of an HIV-1-related AIDS defining event
  2. Death
  3. Change in CD4 cell count between baseline and week 24
  4. Change in plasma HIV-RNA level between baseline and week 4, week 8, week 12 and week 24
  5. Change in genotypic and phenotypic resistance between baseline and week 2

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120783


Locations
France
Service de Medecine Interne hopital Avicenne
Bobigny, France, 93009 cedex
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Odile Launay, MD Hopital Avicenne,Bobigny, Service de Médecine Interne
Study Chair: Dominique Costagliola Inserm U720
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00120783     History of Changes
Other Study ID Numbers: ANRS 109 VISTA
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: January 18, 2007
Last Verified: January 2007

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Indinavir
Lamivudine
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors