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 Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen
- Conditions
- HIV SeropositivityHIV InfectionsHIV-1-infection
- Interventions
- Registration Number
- NCT03333083
- Lead Sponsor
- Judit Pich
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Raltegravir + Lamivudine Raltegravir - Raltegravir + Lamivudine Lamivudine -
- Primary Outcome Measures
Name Time Method Therapeutic failure 48 weeks therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
- Secondary Outcome Measures
Name Time Method Changes from baseline in triglycerides 48 weeks Changes from baseline in insulin resistance (HOMA-IR) 24 weeks Changes from baseline in cholesterol LDL 48 weeks Changes from baseline in cholesterol HDL 48 weeks Changes from baseline in and insulin resistance (HOMA-IR) 48 weeks Changes from baseline in body fat composition 48 weeks Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity 48 weeks Changes on Pittsburgh Sleep Quality Index for neurological toxicity
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 48 weeks Changes on plasma lipids triglycerides
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience 48 weeks Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity 48 weeks Changes on dual energy x-ray absorptiometry bone density
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity 48 weeks Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions 48 weeks Proportion of drug-drug interaction with antirretroviral treatment
Therapeutic failure 24 weeks Virological failure 48 weeks Defined as two consecutive measurements of plasma viral load above 50 copies/ml
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) 48 weeks Changes from baseline in cholesterol total 48 weeks Changes from baseline in HDL 24 weeks Changes from baseline in immune activation markers including CD38 48 weeks Changes from baseline in immune activation markers including HLA-DR 48 weeks Changes from baseline in biomarkers of inflammation IL-6, 48 weeks Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein 48 weeks Changes from baseline in biomarkers of mononuclear activation SD-14 48 weeks Changes from baseline in biomarkers of mononuclear activation SD-163 48 weeks Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) 48 weeks Change from baseline in EQ-5D-5L 48 weeks Incidence of adverse events 48 weeks
Trial Locations
- Locations (1)
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain