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Completed

NCT Number: NCT04034862

Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

For a few years, there has been a keen interest of clinicians and patients for "lighter" antiretroviral strategies based on two- or even single drug regimens rather than the canonical triple therapy, both as initial and maintenance therapy, despite the possibility that ongoing viral replication may occur in some patients under triple-therapy.

We will therefore propose such simplification strategy (DTG/3TC) while maintaining triple-therapy (DTG/ABC/3TC) in a control group and will perform an in depth analysis of the replication-competent reservoir in blood and in tissues as well as measurements of residual viremia and immune chronic activation/inflammation.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Liège university hospital

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV-infected adults receiving cART for at least 2 years
  • DTG/3TC/ABC as cART regimen in the previous 6 months.
  • CD4 counts higher than 200 cells per μL and virological suppression for at least 2 years (plasma HIV RNA <20 copies per mL)

Exclusion criteria

  • hepatitis C or B co-infection
  • unstable liver disease
  • renal impairment (estimated glomerular filtration rate <50 mL per min),
  • gastrointestinal disorders that would affect the absorption of study treatment
  • current use of drugs with significant interactions with dolutegravir
  • current use of drugs with an impact on inflammation such as steroids.
  • hospitalization for acute illness within the previous 8 weeks
  • Pregnancy or breastfeeding.
  • Known resistance to DTG or 3TC
  • Active tuberculosis
  • Anal or rectal lesions impeding rectal biopsies
  • Decreased platelets count or coagulation disorder.

Treatment and study plan

Treatment simplification (dolutegravir lamivudine)

Drug

Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen

Primary outcomes

  1. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues.

    Time frame: 1 year

    Measurements of RCR in the blood and tissues (rectal biopsies)

Secondary outcomes

  1. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.

    Time frame: 1 year

  2. The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.

    Time frame: 1 year

  3. The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.

    Time frame: 1 year

  4. The level of clonal expansion in the blood and tissue RCR

    Time frame: 1 year

  5. The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)

Acronym: IDOLTIB

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2019
Registry last updated
Mar 17, 2025

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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