Dolutegravir

Overview

Dolutegravir is an HIV-1 integrase inhibitor that blocks the strand transfer step of the integration of the viral genome into the host cell (INSTI). The effect of this drug has no homology in human host cells, which gives it excellent tolerability and minimal toxicity. Dolutegravir was developed by ViiV Healthcare and FDA-approved on August 12, 2013. On November 21, 2017, dolutegravir, in combination with rilpivirine, was approved as part of the first complete treatment regimen with only two drugs for the treatment of adults with HIV-1 named Juluca.

Background

Indication

Dolutegravir is indicated in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection that comply with the characteristics of being adults or children aged 12 years and older and present at least a weight of 40 kg. The FDA combination therapy approval of dolutegravir and rilpivirine is indicated for adults with HIV-1 infections whose virus is currently suppressed (< 50 copies/ml) on a stable regimen for at least six months, without history of treatment failure and no known substitutions associated to resistance to any of the two components of the therapy. Dolutegravir is also available in combination with lamivudine and abacavir for the treatment of adult and pediatric patients with HIV-1 who weigh ≥10kg.

Associated Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Title	Posted	Study ID	Phase	Status	Sponsor
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed	2017/04/12	NCT03110380	Phase 3	Completed	Gilead Sciences
The Pharmacokinetics of Dolutegravir, Darunavir/Cobocistat When Co-administered in Healthy Volunteers	2017/03/29	NCT03094507	Phase 1	Completed	St Stephens Aids Trust
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine	2017/03/13	NCT03078556	Phase 1	Completed	ViiV Healthcare
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants	2017/02/09	NCT03048422	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Dolutegravir and Darunavir Evaluation in Adults Failing Therapy	2017/01/11	NCT03017872	Phase 4	Active, not recruiting	Kirby Institute
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019	2017/01/10	NCT03016533	Phase 3	Completed	ViiV Healthcare
National Multicenter Trial Evaluating Two Treatments in Patients with Primary Human Immunodeficiency Virus (HIV-1) Infection	2016/12/09	NCT02987530	Phase 3	Completed	ANRS, Emerging Infectious Diseases
Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection	2016/11/29	NCT02976259	Phase 3	Completed	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Multi Interventional Study Exploring HIV-1 Residual Replication: a Step Towards HIV-1 Eradication and Sterilizing Cure	2016/11/11	NCT02961829	Not Applicable	Completed	Federal University of São Paulo
Dolutegravir in Reservoirs	2016/10/05	NCT02924389	Phase 4	Terminated	Emory University

Title

Posted

Study ID

Phase

Status

Sponsor

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

2017/04/12

NCT03110380

Phase 3

Completed

Gilead Sciences