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

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ClinicalTrials.gov Identifier: NCT02572947
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Calmy Alexandra, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Dolutegravir Monotherapy Treatment Efficacy Drug: Dolutegravir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Dolutegravir monotherapy
10 patients will be simplified to monotherapy of dolutegravir tablet 50mg once daily for 24 weeks
Drug: Dolutegravir



Primary Outcome Measures :
  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 [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. Quantification of the HIV-1 DNA reservoir in peripheral blood monocyte cells at baseline and week 24 [ Time Frame: week 24 ]
  2. Emergence of genotypic resistance in plasma HIV-1 RNA in case of virological failure [ Time Frame: week 24 ]
  3. Quantification HIV-1 RNA levels in the CSF and semen at baseline and week 24 [ Time Frame: week 24 ]
    Lumbar puncture is optional at baseline

  4. Change from baseline CD4 cell count from baseline at week 24 [ Time Frame: week 24 ]
  5. Adherence to medication at weeks 4, 8, 12, 16, 20, 24 [ Time Frame: week 24 ]
    Number of participants with suboptimal adherence defined as more than 3 pills (10%) remaining from previous monthly visit OR missed more than one dose in a row OR missed dose more than once every two weeks

  6. Lipidic profile changes from baseline at week 24 [ Time Frame: week 24 ]
  7. Body fat composition as measured by dual energy x-ray absorptiometry (DXA) scan at baseline and week 24 [ Time Frame: week 24 ]
  8. Change in bone mineral density from baseline to week 24 [ Time Frame: week 24 ]
    Number of patients with normal bone density, osteopenia or osteoporosis as defined by DXA scans results


Other Outcome Measures:
  1. Change in immune activation from baseline to week 24 measured by highly sensitive C-reactive protein (mg/l) [ Time Frame: week 24 ]
  2. Change in immune activation from baseline to week 24 measured by cytokines (pg/ml) [ Time Frame: week 24 ]
  3. Change in immune activation from baseline to week 24 measured by d-dimers (microg/l) [ Time Frame: week 24 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572947


Locations
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Switzerland
University Hospitals of Geneva, HIV unit
Geneva, Switzerland, 1205
Sponsors and Collaborators
Calmy Alexandra
Investigators
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Principal Investigator: Delphine Sculier, MD University Hospital, Geneva

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Responsible Party: Calmy Alexandra, Médecin adjointe agrégée, HIV Unit director, Infectious Diseases Division, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02572947     History of Changes
Other Study ID Numbers: PRD-13-2015-I
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Keywords provided by Calmy Alexandra, University Hospital, Geneva:
Dolutegravir
HIV infection
Anti-Retroviral Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Dolutegravir
Integrase Inhibitors
HIV Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents