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

• Status: Completed
• Trial end date: 2018-09-21

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.

• Phase: Phase 3

Details

• Lead Sponsor: University Hospital, Tours
• Collaborators: Central Hospital, Nancy, France; Central Hospital, NIORT; Centre Hospitalier de La Rochelle; Henri Mondor University Hospital; HOSPITAL, CAEN; HOSPITAL, CHARTRES; HOSPITAL, FOCH; HOSPITAL, HENRI MONDOR; HOSPITAL, HOTEL DIEU; HOSPITAL, NIORT; HOSPITAL, ORLEANS; HOSPITAL, SAINT LOUIS; HOSPITAL, SAINTES; Poitiers University Hospital; Tenon Hospital, Paris; Tourcoing Hospital; University Hospital, Rouen
• Treatments: Atazanavir Sulfate; Cobicistat; Darunavir; Dolutegravir; Efavirenz; Elvitegravir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Enfuvirtide; Etravirine; Fosamprenavir; HIV Protease Inhibitors; Indinavir; Integrase Inhibitors; Lopinavir; Maraviroc; Nevirapine; Protease Inhibitors; Raltegravir Potassium; Reverse Transcriptase Inhibitors; Rilpivirine; Ritonavir; Saquinavir; Tenofovir; Tipranavir