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

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.

Inclusion Criteria:

• HIV-1 infection;
• Patient included in the Swiss HIV Cohort Study (SHCS);
• ≥ 18 years of age;
• Virologically suppressed for at least 24 months on first line triple ART (changes for toxicity permitted) with at least 4 HIV-1 RNA measurements in plasma <50 copies/ml;
• No history of previous failure on ART;
• No documented antiretroviral drugs resistance;
• No co-infection with Hepatitis B or C virus;
• Effective contraception in women;
• Willing to provide CSF and semen samples;
• Written informed consent

Exclusion Criteria:

• HIV-2 infection;
• Renal dysfunction (creatinine clearance <50ml/min);
• aspartate transaminase or alanine aminotransferase >5x upper limit normal;
• Concomitant use of carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, rifampicin or metformin;
• Previous AIDS defining conditions or active malignancy in the past five years;
• Positive HIV viral load in CSF at baseline;
• Known or suspected non-compliance;
• Women who are pregnant or breastfeeding.