HIV-1-infection, HIV Infections, HIV Seropositivity
Conditions
Keywords
Raltegravir, Lamivudine
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)
Interventions
DRUGRaltegravir
Raltegravir (1200 mg QD)
DRUGLamivudine
Lamivudine (300 mg QD)
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Judit Pich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Therapeutic Failure | 48 weeks | Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Cholesterol Total | 24 weeks | — |
| Changes From Baseline in Cholesterol LDL | 24 weeks | — |
| Changes From Baseline in Cholesterol HDL | 24 weeks | — |
| Changes From Baseline in Triglycerides | 24 weeks | — |
| Changes From Baseline in Insulin Resistance (HOMA-IR) | 24 weeks | — |
| Change From Baseline in Lumbar and Femoral Bone Mineral Density | 48 weeks | — |
| Change From Baseline in Plasma 25-OH Vitamin D Levels | 48 weeks | — |
| Change From Baseline in Urine Beta-2-microglobulin | 48 weeks | — |
| Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI) | 48 weeks | — |
| Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir | 48 weeks | — |
| Changes From Baseline in Biomarkers of Inflammation IL-6 | 48 weeks | — |
| Changes From Baseline in Biomarker of Mononuclear Activation SD-163 | 48 weeks | — |
| Changes From Baseline in Biomarker of Mononuclear Activation SD-14 | 48 weeks | — |
| Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein | 48 weeks | — |
| Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at | 48 weeks | — |
| Change From Baseline in EQ-5D-5L | 48 weeks | — |
| Incidence of Adverse Events | 48 weeks | — |
| Viral Load | 48 weeks | Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks |
| Change From Baseline in Urine Protein/Creatinine Ratio | 48 weeks | — |
Countries
Spain
Participant flow
Recruitment details
All trial subjects were recruited at a single site in Spain: Hospital Clínic de Barcelona. The subjects were patients in the switch arm who completed the 24-week follow-up of RALAM (NCT02284035) study and remained virologically suppressed (viral load \<50 copies/mL) on dual therapy with 3TC plus Raltegravir. Recruitment start period: 02-May-2018.
Pre-assignment details
Selection and baseline will be done in the same visit. Performed at Week 0. During this visit, written informed consent was obtained from each patient, and demographic data, medical history, complete physical examination, and laboratory tests (including hematology, biochemistry, and plasma viral load) were performed to confirm eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Raltegravir + Lamivudine Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD) | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 1 |
Baseline characteristics
| Characteristic | Raltegravir + Lamivudine |
|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 16 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Proportion of Patients With Therapeutic Failure
Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death.
Time frame: 48 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Raltegravir + Lamivudine | Proportion of Patients With Therapeutic Failure | Patients without therapeutic failure | 30 Participants |
| Raltegravir + Lamivudine | Proportion of Patients With Therapeutic Failure | Patients with therapeutic failure | 3 Participants |
Secondary
Change From Baseline in EQ-5D-5L
Time frame: 48 weeks
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI)
Time frame: 48 weeks
Secondary
Change From Baseline in Lumbar and Femoral Bone Mineral Density
Time frame: 48 weeks
Secondary
Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir
Time frame: 48 weeks
Secondary
Change From Baseline in Plasma 25-OH Vitamin D Levels
Time frame: 48 weeks
Secondary
Change From Baseline in Urine Beta-2-microglobulin
Time frame: 48 weeks
Secondary
Change From Baseline in Urine Protein/Creatinine Ratio
Time frame: 48 weeks
Secondary
Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein
Time frame: 48 weeks
Secondary
Changes From Baseline in Biomarker of Mononuclear Activation SD-14
Time frame: 48 weeks
Secondary
Changes From Baseline in Biomarker of Mononuclear Activation SD-163
Time frame: 48 weeks
Secondary
Changes From Baseline in Biomarkers of Inflammation IL-6
Time frame: 48 weeks
Secondary
Changes From Baseline in Cholesterol HDL
Time frame: 24 weeks
Secondary
Changes From Baseline in Cholesterol LDL
Time frame: 24 weeks
Secondary
Changes From Baseline in Cholesterol Total
Time frame: 24 weeks
Secondary
Changes From Baseline in Insulin Resistance (HOMA-IR)
Time frame: 24 weeks
Secondary
Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at
Time frame: 48 weeks
Secondary
Changes From Baseline in Triglycerides
Time frame: 24 weeks
Secondary
Incidence of Adverse Events
Time frame: 48 weeks
Secondary
Viral Load
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks
Time frame: 48 weeks