NCT02572947

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

October 7, 2015

Last Update Submit

October 31, 2017

Conditions

Human Immunodeficiency VirusDolutegravirMonotherapyTreatment Efficacy

Keywords

DolutegravirHIV infectionAnti-Retroviral AgentsHIV Integrase InhibitorsIntegrase InhibitorsPharmacologic ActionsTherapeutic Uses

Outcome Measures

Primary Outcomes (1)

  • Number of patients without virological failure defined as plasma HIV-1 RNA ≥ 200 copies/ml on two consecutive measurements or positive HIV-1 RNA level in cerebrospinal fluid (CSF) at week 24 or before

    week 24

Secondary Outcomes (8)

  • Quantification of the HIV-1 DNA reservoir in peripheral blood monocyte cells at baseline and week 24

    week 24

  • Emergence of genotypic resistance in plasma HIV-1 RNA in case of virological failure

    week 24

  • Quantification HIV-1 RNA levels in the CSF and semen at baseline and week 24

    week 24

  • Change from baseline CD4 cell count from baseline at week 24

    week 24

  • Adherence to medication at weeks 4, 8, 12, 16, 20, 24

    week 24

  • +3 more secondary outcomes

Other Outcomes (3)

  • Change in immune activation from baseline to week 24 measured by highly sensitive C-reactive protein (mg/l)

    week 24

  • Change in immune activation from baseline to week 24 measured by cytokines (pg/ml)

    week 24

  • Change in immune activation from baseline to week 24 measured by d-dimers (microg/l)

    week 24

Study Arms (1)

Dolutegravir monotherapy

EXPERIMENTAL

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

Drug: Dolutegravir

Interventions

DolutegravirDRUG
Dolutegravir monotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Geneva, HIV unit

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Interventions

dolutegravir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Delphine Sculier, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Médecin adjointe agrégée, HIV Unit director, Infectious Diseases Division

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 9, 2015

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

CH(1)