MedDataX Logo

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

NCT ID: NCT02572947

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus Dolutegravir Monotherapy Treatment Efficacy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dolutegravir HIV infection Anti-Retroviral Agents HIV Integrase Inhibitors Integrase Inhibitors Pharmacologic Actions Therapeutic Uses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dolutegravir monotherapy

10 patients will be simplified to monotherapy of dolutegravir tablet 50mg once daily for 24 weeks

Group Type EXPERIMENTAL

Dolutegravir

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dolutegravir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Calmy Alexandra

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Calmy Alexandra

Médecin adjointe agrégée, HIV Unit director, Infectious Diseases Division

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Delphine Sculier, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals of Geneva, HIV unit

Geneva, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRD-13-2015-I

Identifier Type: -

Identifier Source: org_study_id