Efficacy and Tolerability of an Antiretroviral Bi-Therapy... | NCT00120783

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

NCT00120783

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Status

Terminated

Last Update Posted

Jan 18, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

HIV Infections

Interventions

Indinavir
Lamivudine
Ritonavir

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Aug 2003

First Submitted Date

Jul 12, 2005

First Submission Date that Met QC Criteria

Jul 18, 2005

First Posted Date

Jul 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2007

Last Update Posted Date

Jan 18, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

French National Agency for Research on AIDS and Viral HepatitisOTHER_GOV

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Development of an HIV-1-related AIDS defining event
Death
Change in CD4 cell count between baseline and week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Medecine Interne hopital Avicenne		Bobigny		93009 cedex	France

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019469	Indinavir
D019259	Lamivudine
D019438	Ritonavir

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D016047	Zalcitabine

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Indinavir	Drug
Lamivudine	Drug
Ritonavir	Drug