Clinical trial NCT03333083: 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
Official title: 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 Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen. (RALAM-II Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV Seropositivity
HIV Infections
HIV-1-infection
Keywords: Lamivudine
Raltegravir
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2017-11-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic failure
timeFrame: 48 weeks
Secondary outcomes:
measure: Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience
timeFrame: 48 weeks
measure: Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity
timeFrame: 48 weeks
measure: 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
timeFrame: 48 weeks
measure: 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
timeFrame: 48 weeks
measure: 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
timeFrame: 48 weeks
measure: Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity
timeFrame: 48 weeks
measure: Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity
timeFrame: 48 weeks
measure: Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions
timeFrame: 48 weeks
measure: Therapeutic failure
timeFrame: 24 weeks
measure: Virological failure
timeFrame: 24 weeks
measure: Virological failure
timeFrame: 48 weeks
measure: Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)
timeFrame: 48 weeks
measure: Changes from baseline in cholesterol total
timeFrame: 24 weeks
measure: Changes from baseline in HDL
timeFrame: 24 weeks
measure: Changes from baseline in triglycerides
timeFrame: 24 weeks
measure: Changes from baseline in insulin resistance (HOMA-IR)
timeFrame: 24 weeks
measure: Changes from baseline in cholesterol LDL
timeFrame: 24 weeks
measure: Changes from baseline in cholesterol LDL
timeFrame: 48 weeks
measure: Changes from baseline in cholesterol total
timeFrame: 48 weeks
measure: Changes from baseline in cholesterol HDL
timeFrame: 48 weeks
measure: Changes from baseline in triglycerides
timeFrame: 48 weeks
measure: Changes from baseline in and insulin resistance (HOMA-IR)
timeFrame: 48 weeks
measure: Changes from baseline in body fat composition
timeFrame: 48 weeks
measure: Changes from baseline in immune activation markers including CD38
timeFrame: 48 weeks
measure: Changes from baseline in immune activation markers including HLA-DR
timeFrame: 48 weeks
measure: Changes from baseline in biomarkers of inflammation IL-6,
timeFrame: 48 weeks
measure: Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein
timeFrame: 48 weeks
measure: Changes from baseline in biomarkers of mononuclear activation SD-14
timeFrame: 48 weeks
measure: Changes from baseline in biomarkers of mononuclear activation SD-163
timeFrame: 48 weeks
measure: Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
timeFrame: 24 weeks
measure: Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
timeFrame: 48 weeks
measure: Change from baseline in EQ-5D-5L
timeFrame: 24 weeks
measure: Change from baseline in EQ-5D-5L
timeFrame: 48 weeks
measure: Incidence of adverse events
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
Study officials:
References: