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NCT Number: NCT02572947

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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Dolutegravir Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Monotherapy RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Efficacy Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals of Geneva, HIV unit

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dolutegravir

Drug

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

    Time frame: week 24

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Calmy Alexandra

Other

Registry information

Official study 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

Acronym: MONODO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2015
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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