Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been terminated.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00120783
First received: July 12, 2005
Last updated: January 17, 2007
Last verified: January 2007
History of Changes
  Purpose

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


Condition Intervention Phase
HIV Infections
 Drug: Indinavir
Drug: Lamivudine
Drug: Ritonavir
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Indinavir
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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:
  • 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
Estimated Enrollment: 40
Study Start Date: February 2002
Estimated Study Completion Date: August 2003
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00120783     History of Changes
Other Study ID Numbers: ANRS 109 VISTA
Study First Received: July 12, 2005
Last Updated: January 17, 2007
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:
Treatment Failure
HIV infections

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

ClinicalTrials.gov processed this record on March 01, 2015