Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
NCT ID: NCT04904406
Last Updated: 2024-05-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
81 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-10-22
Study Completion Date
2023-12-01
Brief Summary
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Randomized controlled parallel open-label study in people living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.
Participants (n=95) are randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.
Participants (n=95) are randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.
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Detailed Description
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In the MRI sub study 40 patients from the main study (20 from each group) are included. A cardiac MRI are performed at baseline and week 48 to evaluate cardiac effects of abacavir.
Conditions
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Hiv
HIV Infections
HIV Cardiomyopathy
Weight Change, Body
HIV Lipodystrophy
Cardiovascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A randomized controlled open-label superiority trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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dolutegravir/lamivudine
50 mg dolutegravir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Group Type
EXPERIMENTAL
Dolutegravir / Lamivudine Oral Tablet
Intervention Type
DRUG
Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine
dolutegravir/abacavir/lamivudine
50 mg dolutegravir, 600 mg abacavir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Dolutegravir / Lamivudine Oral Tablet
Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine
Intervention Type
DRUG
Other Intervention Names
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Dolutegravir/abacavir/lamivudine
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years old
* Diagnosed HIV
* At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine
* Plasma viral load (HIV-RNA) \< 50 copies/ml at inclusion
For women of childbearing potential:
* Negative pregnancy test
* Willingness to use contraceptive (consistent with local regulations) during study period
* Diagnosed HIV
* At least 6 months of ongoing treatment with dolutegravir/ abacavir/lamivudine
* Plasma viral load (HIV-RNA) \< 50 copies/ml at inclusion
For women of childbearing potential:
* Negative pregnancy test
* Willingness to use contraceptive (consistent with local regulations) during study period
Exclusion Criteria
* Pre-existing viral resistance mutations to lamivudine or to dolutegravir
* Presence of hepatitis B antigen (HBsAg) or Hepatitis B virus DNA (HBV DNA)
* Cancer within past 5 years
* Diabetes, cardiovascular disease or other chronic illness considered stable as assessed by the treating physician
For women of childbearing potential:
* Pregnancy
* Breastfeeding
* Presence of hepatitis B antigen (HBsAg) or Hepatitis B virus DNA (HBV DNA)
* Cancer within past 5 years
* Diabetes, cardiovascular disease or other chronic illness considered stable as assessed by the treating physician
For women of childbearing potential:
* Pregnancy
* Breastfeeding
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Thomas Benfield
OTHER
Sponsor Role
lead
Responsible Party
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Thomas Benfield
MD, DMsc, professor,
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Thomas Benfield, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious diseases, Hvidovre Hospital, Denmark
Locations
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Copenhagen University Hospital - Rigshospitalet
Copenhagen, , Denmark
Site Status
Copenhagen University Hospital, Amager Hvidovre
Hvidovre, , Denmark
Site Status
Countries
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Denmark
References
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Reference Type
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Other Identifiers
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H-20011433
Identifier Type: -
Identifier Source: org_study_id
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