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Study to Evaluate the Efficacy of MONotherapy of TiviCAY® Versus a Triple Therapy in HIV-1-infected Patients

NCT02596334 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2018-11-13

No results posted yet for this study

Summary

Triple antiretroviral regimens have greatly improved the prognosis of patients living with HIV (PLHIV). Patients virologically controlled and having a good immune restoration can have a life expectancy close or equal to that of people not infected with HIV.\[1\] However, this is under the condition of a "lifetime" maintenance of an undetectable plasma viral load (pVL) (\<50 cp/ml). On the other hand it is well established that aging increases comorbidities among PLHIV and the burden of co-medications.\[2\] This also has the consequence of frequent drug-drug interactions. In this context it is important to decrease pills burden, side-effects and drug-drug interactions, while maintaining undetectability.

Currently, there is a strong interest for medical research to validate lightened regimens (i.e. bithérapies \[3-7\] and monothérapies \[8,9\], particularly in a maintenance strategy, with the primary objective of reducing burden of pills and side effects. Several monotherapy trials using a boosted protease inhibitor (PI/r) showed high level of viral suppression, even if this proportion was not always non-inferior to maintaining a triple therapy. \[8,9\] Fortunately, when virological failure occurred under monotherapy virologic suppression was easily restored by the addition of two NRTI. Patients who are most likely to maintain viral suppression under a reduced scheme are those that have a high nadir (\> 100 CD4 / mm3), no previous AIDS event and a sustained virologic suppression (\>12 months).

Monotherapy is the option that best reduces the burden of pills and the risk of side effects or drug-drug interactions. It must be considered using very powerful molecule that harbor a strong binding to its ligand in order to minimize the risk of selecting resistant mutants in the case of virologic failure. To be as simple as possible in its use, it must be a single agent administered as a single dose once a day and not boosted if possible. The molecule must have very good tolerance. Finally, to be effective in viral sanctuaries this molecule should have a good (or sufficient) diffusion to ensure effective Cmin on wild viral strains. Dolutegravir meets all these exigences.\[10\] In addition, our team recently presented results of a pilot study showing that the switch of a successful combined antiretroviral regimen to dolutegravir monotherapy maintained undetectable viral load (\<20 cp/ml) after a median of 7 months (range 6.5-10 months).

Conditions

Interventions

DRUG

dolutegravir 50mg +abacavir 600mg +lamivudine 300mg

DRUG

dolutegravir

Sponsors & Collaborators

  • Centre Hospitalier Régional d'Orléans

    lead OTHER

Principal Investigators

  • HOCQUELOUX Laurent · CHR d'ORLEANS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-23
Primary Completion
2017-06-23
Completion
2018-06-23

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02596334 on ClinicalTrials.gov