A Phase 4 interventional study of Dolutegravir / Lamivudine Oral Tablet in Hiv, HIV Infections and HIV Cardiomyopathy, sponsored by Thomas Benfield. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Thomas Benfield · Phase 4, Interventional, and Treatment
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 81 is close to the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Thomas Benfield is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Compared within HIV Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For women of :
Exclusion Criteria:
For women of :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 mg dolutegravir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Drug: Dolutegravir / Lamivudine Oral Tablet
50 mg dolutegravir, 600 mg abacavir and 300 mg lamivudine (co-formulated) once daily for 48 weeks
Drug pages: Dolutegravir · Lamivudine
Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine
Also known as: Dolutegravir/abacavir/lamivudine
Changes in body weight of ≥2 kg
Fasting body weight
Time frame: 48 weeks
Virological control
HIV-RNA \<50 copies/ml
Time frame: 48 weeks
Changes in self-rated health
12-item Short Form Health Survey (SF-12). Scores from 0 (worse) to 100 (best).
Time frame: 48 weeks
Change in metabolism
Impaired insulin resistance and/or β-cell function determined by changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 48 weeks
Changes in cardiac risk
D:A:D CVD risk score: Five and ten years predicted cardio vascular disease risk (percent)
Time frame: 48 weeks
Changes in carotid artery intima-media thickness (cIMT)
Measured by ultrasound.
Time frame: 48 weeks
Changes in Coronary artery calcium score (CACS)
Measures by CT-scan. Scores from 0 and with no upper limit. The higher score, the worse calcification/plaque level and higher CVD risk.
Time frame: 48 weeks
Changes in cardiac blood markers
Changes in N-terminal pro-B-type natriuretic peptide (Pro-BNP)
Time frame: 48 weeks
Changes in bloodpressure
Systolic and diastolic blood pressure (mmHg)
Time frame: 48 weeks
Changes in fat distribution VAT/SAT
Measured by CT-scan • Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by abdominal CT.
Time frame: 48 weeks
Changes in liver stiffness
Measured by CT-scan and liver elastography
Time frame: 48 weeks
Changes in liver fat infiltration
Measured by CT-scan and liver elastography
Time frame: 48 weeks
Changes in fat distribution in trunk, limb and extremities
Measured by dual energy xray absorptiometry (DEXA)
Time frame: 48 weeks
Changes in inflammation
High-sensitive C-reactive protein
Time frame: 48 weeks
Changes in interleukins
Interleukin 1- and interleukin 6
Time frame: 48 weeks
Changes in endothelial function
Vascular cell adhesion molecule 1 and intercellular adhesion molecule 1
Time frame: 48 weeks
Changes in soluble P-selectin
soluble P-selectin
Time frame: 48 weeks
Changes in soluble glycoprotein VI
soluble glycoprotein VI
Time frame: 48 weeks
Changes in d-dimer
D-dimer
Time frame: 48 weeks
Changes in coagulation
Factor 2, 7 and 10 (extrinsic pathway)
Time frame: 48 weeks
Changes in fibrinogen
Fibrinogen
Time frame: 48 weeks
Changes in blood Hemoglobin
Hemoglobin
Time frame: 48 weeks
Changes in blood platelets
Platelets
Time frame: 48 weeks
Changes in plasma creatinine
Creatinine
Time frame: 48 weeks
Changes in plasma urea
Urea
Time frame: 48 weeks
Changes in plasma sodium
Sodium
Time frame: 48 weeks
Changes in plasma potassium
Potassium
Time frame: 48 weeks
Changes in plasma bilirubin
Bilirubin
Time frame: 48 weeks
Changes in plasma alanine
Alanine
Time frame: 48 weeks
Changes in plasma aminotransferase
Aminotransferase
Time frame: 48 weeks
Cardiovascular risk
Framingham risk score: Estimated 10 years risk of cardiovascular disease (percent)
Time frame: 48 weeks
Cardiac biomarkers
Changes in Troponin T (TnT)
Time frame: 48 weeks
Cardiac MRI substudy primary outcome (composite) ECV
Cardiac MRI applied on 40 patients to evaluate: Decrease in extracellular myocardial volume (ECV) from baseline to week 48
Time frame: 48 weeks
Cardiac MRI substudy primary outcome (composite) atrial volume
Cardiac MRI applied on 40 patients to evaluate: Decrease in left atrial volume from baseline to week 48
Time frame: 48 weeks
Cardiac MRI substudy primary outcome (composite) diastolic function
Cardiac MRI applied on 40 patients to evaluate: Improvement in diastolic function from baseline to week 48
Time frame: 48 weeks
Cardiac MRI substudy primary outcome (composite) myocardial mass
Cardiac MRI applied on 40 patients to evaluate: Reduction in myocardial mass from baseline to week 48
Time frame: 48 weeks
Cardiac MRI substudy secondary outcome ejection fraction (EF)
Cardiac MRI applied on 40 patients to evaluate: Secondary outcomes Changes in: • Ejection fraction (EF)
Time frame: 48 weeks
Cardiac MRI substudy secondary outcome perfusion
Cardiac MRI applied on 40 patients to evaluate: Secondary outcomes Changes in: • Perfusion
Time frame: 48 weeks
Cardiac MRI substudy secondary outcome edema/inflammation
Cardiac MRI applied on 40 patients to evaluate: Secondary outcomes Changes in: • Edema/inflammation
Time frame: 48 weeks
Cardiac MRI substudy secondary outcome fibrosis
Cardiac MRI applied on 40 patients to evaluate: Secondary outcomes Changes in: • Fibrosis
Time frame: 48 weeks
Cardiac MRI substudy secondary outcome lipid
Cardiac MRI applied on 40 patients to evaluate: Secondary outcomes Changes in: • Lipid-water profile Measured by MR spectroscopy
Time frame: 48 weeks
Plan to share: No
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Studies of the drugs tested here: Dolutegravir · Lamivudine
Thomas Benfield