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

Tracking Information

First Received Date ^ICMJE

July 12, 2005

Last Updated Date

January 17, 2007

Start Date ^ICMJE

February 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00120783 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial.

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Indinavir
Drug: Lamivudine
Drug: Ritonavir

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

August 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00120783

Other Study ID Numbers ^ICMJE

ANRS 109 VISTA

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Odile Launay, MD	Hopital Avicenne,Bobigny, Service de Médecine Interne
Study Chair:	Dominique Costagliola	Inserm U720

PRS Account

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

January 2007

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

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