NCT02572947

A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients

An Interventional, One-arm, Open Label Pilot Study to Assess the Feasibility of Dolutegravir Monotherapy in Virologically Suppressed Patients on Conventional Triple Antiretroviral Therapy of Dolutegravir Plus Two Nucleoside Reverse Transcriptase Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Calmy Alexandra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Current HIV treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (ART). Simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing virological failure.

Conditions

• Human Immunodeficiency Virus
• Dolutegravir
• Monotherapy
• Treatment Efficacy

Interventions

Type	Name	Description
DRUG	Dolutegravir

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2015-10-09
• Last updated: 2017-11-01

Locations

1 site across 1 country: Switzerland