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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03333083
Other study ID # 2017-000985-31
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 3, 2018
Est. completion date March 30, 2020

Study information

Verified date July 2018
Source Hospital Clinic of Barcelona
Contact Esteban Martinez, MD
Phone +34.93.227.54.00
Email ESTEBANM@clinic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.

- Patients seropositive for HIV-1 using standard diagnostic criteria.

- Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen

- Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).

- Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

- Pregnancy, lactation, or planned pregnancy during the study period.

- Previous failure to an integrase inhibitor-containing regimen.

- Previous failure to a Lamivudine or Emtricitabine-containing regimen.

- Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.

- Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.

- Chronic hepatitis B.

Study Design


Intervention

Drug:
Raltegravir
Raltegravir (1200 mg once a day)
Lamivudine
Lamivudine (300 mg once a day)

Locations

Country Name City State
Spain Hospital Clínic i Provincial de Barcelona Barcelona

Sponsors (2)

Lead Sponsor Collaborator
David Garcia Cinca Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic failure therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity Changes on Pittsburgh Sleep Quality Index for neurological toxicity 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity Changes on plasma lipids cholesterol LDL 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity Changes on plasma lipids cholesterol HDL 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity Changes on plasma lipids triglycerides 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity Changes on dual energy x-ray absorptiometry bone density 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort 48 weeks
Secondary Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions Proportion of drug-drug interaction with antirretroviral treatment 48 weeks
Secondary Therapeutic failure 24 weeks
Secondary Virological failure Defined as two consecutive measurements of plasma viral load above 50 copies/ml 24 weeks
Secondary Virological failure Defined as two consecutive measurements of plasma viral load above 50 copies/ml 48 weeks
Secondary Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) 48 weeks
Secondary Changes from baseline in cholesterol total 24 weeks
Secondary Changes from baseline in HDL 24 weeks
Secondary Changes from baseline in triglycerides 24 weeks
Secondary Changes from baseline in insulin resistance (HOMA-IR) 24 weeks
Secondary Changes from baseline in cholesterol LDL 24 weeks
Secondary Changes from baseline in cholesterol LDL 48 weeks
Secondary Changes from baseline in cholesterol total 48 weeks
Secondary Changes from baseline in cholesterol HDL 48 weeks
Secondary Changes from baseline in triglycerides 48 weeks
Secondary Changes from baseline in and insulin resistance (HOMA-IR) 48 weeks
Secondary Changes from baseline in body fat composition 48 weeks
Secondary Changes from baseline in immune activation markers including CD38 48 weeks
Secondary Changes from baseline in immune activation markers including HLA-DR 48 weeks
Secondary Changes from baseline in biomarkers of inflammation IL-6, 48 weeks
Secondary Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein 48 weeks
Secondary Changes from baseline in biomarkers of mononuclear activation SD-14 48 weeks
Secondary Changes from baseline in biomarkers of mononuclear activation SD-163 48 weeks
Secondary Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) 24 weeks
Secondary Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) 48 weeks
Secondary Change from baseline in EQ-5D-5L 24 weeks
Secondary Change from baseline in EQ-5D-5L 48 weeks
Secondary Incidence of adverse events 48 weeks
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