Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy

Summary

In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment.

The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments.

Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction.

Currently, a small number of patients is being successfully treated in the long-term (viral load \< 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated.

The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (\< 2,7 log copies/106 PBMC).

Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.

Conditions

• HIV

Interventions

DRUG

triple therapy

Dosage treatment and usual prescription

DRUG

dual therapy

1 tablet (200mg/245mg) daily for 48 weeks

Sponsors & Collaborators

• HOSPITAL, ORLEANS

  collaborator UNKNOWN

• Poitiers University Hospital

  collaborator OTHER

• Centre Hospitalier de La Rochelle

  collaborator OTHER

• HOSPITAL, SAINTES

  collaborator UNKNOWN

• HOSPITAL, FOCH

  collaborator UNKNOWN

• HOSPITAL, CAEN

  collaborator UNKNOWN

• Henri Mondor University Hospital

  collaborator OTHER

• HOSPITAL, HOTEL DIEU

  collaborator UNKNOWN

• HOSPITAL, CHARTRES

  collaborator UNKNOWN

• HOSPITAL, SAINT LOUIS

  collaborator UNKNOWN

• Tourcoing Hospital

  collaborator OTHER

• Central Hospital, NIORT

  collaborator UNKNOWN

• Tenon Hospital, Paris

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• University Hospital, Tours

  lead OTHER

Principal Investigators

• LOUIS BERNARD, Pr · CHRU de TOURS

• GWENAEL LE MOAL, Dr · Poitiers University Hospital

• MARIAM RONCATO- SABERAN, Dr · CH de LA ROCHELLE

• THIERRY PASDELOUPS, Dr · CH de SAINTES

• DAVID ZUCMAN, Dr · HOPITAL de FOCH

• RENAUD VERDON, Pr · University Hospital, Caen

• SEBASTIEN GALLIEN, Pr · CHU d'HENRI MONDOR

• JEAN - PAUL VIARD, Pr · CH d'HOTEL DIEU

• MARC LESTELLE, Dr · CH de CHARTRES

• JEAN - MICHEL MOLINA, Pr · CHU SAINT LOUIS

• FAÏZA AJANA, Dr · CH de TOURCOING

• SIMON SUNDER, Dr · CH de NIORT

• Gilles PIALOUX, Pr · HOSPITAL TENON

• Thierry MAY, Dr · Central Hospital, Nancy, France

• Manuel ETIENNE, Dr · University Hospital, Rouen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2017-08-23

Completion

2018-09-21

Countries

• France

Study Locations