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Completed

NCT Number: NCT04166474

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Desmond Tutu Health Foundation, Cape Town, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to give informed consent prior to participation
  • Willing and able to comply with all study requirements
  • Receiving standard doses of RIF and INH
  • HIV antibody negative
  • Male or non-pregnant, non-breastfeeding female
  • Study participation will not extend length of ATT by more than 4 weeks

Exclusion criteria

  • < 18 years
  • Body weight < 50 kg
  • eGFR < 60 mL/min
  • Abnormal LFTs including ALT > 2.5 ULN
  • HIV antibody positive
  • Non-standard TB regimen (containing RHZE)
  • Women of childbearing age unless using effective contraception
  • Family history of sudden cardiac death
  • Prior history of cardiac disease that precludes the use of low dose digoxin
  • Medical or psychiatric condition that might affect participation in the study based on investigator judgement
  • Regular consumption of grapefruit or grapefruit juice
  • ECG abnormalities that preclude the use of low dose digoxin (intermittent complete heart block, second degree AV block, supraventricular arrhythmia associated with conducting pathways, ventricular tachycardia or fibrillation)

Treatment and study plan

Dolutegravir

Drug

Dosed at 50 mg bd on 3 separate occasions with low, medium and high doses of rifampicin. Dosed at 50 mg od without rifampicin.

Primary outcomes

  1. Change in pharmacokinetic parameter Cmin of dolutegravir

    Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment

    Change in dolutegravir Cmin when dosed with standard, medium, high dose rifampicin

Secondary outcomes

  1. Change in pharmacokinetic parameter AUC of dolutegravir

    Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment

    Change in dolutegravir AUC when dosed with standard, medium, high dose rifampicin

  2. Change in pharmacokinetic parameter Cmax of dolutegravir

    Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment

    Change in dolutegravir Cmax when dosed with standard, medium, high dose rifampicin

  3. Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)

    Time frame: From first dose of dolutegravir until study completion approximately 2 years

    Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)

Sponsors and collaborators

Lead sponsor

Helen Reynolds

Other

Collaborators

  • Desmond Tutu HIV Centre
  • Infectious Disease Institute, Kampala, Uganda

Registry information

Acronym: DoRIS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2019
Registry last updated
Aug 13, 2024

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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