Clinical trial NCT03311945: Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM
Official title: Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Clinical Trial (NCT02284035)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
HIV-1-infection
HIV Seropositivity
Keywords: Raltegravir
Lamivudine
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2017-10-17
Enrollment: 49
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, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)


Eligibility criteria: Inclusion Criteria:

* Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load \<50 copies/mL) on dual therapy with lamivudine plus Raltegravir
* Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

* Pregnancy, lactation, or planned pregnancy during the study period
* Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment
* Hepatitis B co-infection

Primary outcomes:
measure: Proportion of patients with herapeutic failure
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of patients with herapeutic failure
timeFrame: 24 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: Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir
timeFrame: 48 weeks
measure: Changes from baseline in cholesterol total
timeFrame: 24 weeks
measure: Changes from baseline in cholesterol LDL
timeFrame: 24 weeks
measure: Changes from baseline in cholesterol 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 total
timeFrame: 48 weeks
measure: Changes from baseline in cholesterol LDL
timeFrame: 48 weeks
measure: Changes from baseline in triglycerides
timeFrame: 48 weeks
measure: Changes from baseline in insulin resistance (HOMA-IR)
timeFrame: 48 weeks
measure: Change from baseline in lumbar and femoral bone mineral density
timeFrame: 48 weeks
measure: Change from baseline in plasma 25-OH vitamin D levels
timeFrame: 48 weeks
measure: Change from baseline in urine beta-2-microglobulin
timeFrame: 48 weeks
measure: Change from baseline in estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology CollaborationI)
timeFrame: 48 weeks
measure: Change from baseline in urine protein/creatinine ratio
timeFrame: 48 weeks
measure: Changes from baseline in biomarkers of inflammation IL-6
timeFrame: 48 weeks
measure: Changes from baseline in biomarker of mononuclear activation SD-163
timeFrame: 48 weeks
measure: Changes from baseline in biomarker of mononuclear activation SD-14
timeFrame: 48 weeks
measure: Changes from baseline in biomarker of inflammation high sensitivity C-reactive protein
timeFrame: 48 weeks
measure: Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at
timeFrame: 48 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: