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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03311945
Other study ID # 2017-000986-60
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 +34.227.54.00
Email ESTEBANM@clinic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 49
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:

- 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

Study Design


Intervention

Drug:
Raltegravir
Raltegravir (1200 mg QD)
Lamivudine
Lamivudine (300 mg QD)

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 Proportion of patients with herapeutic 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 48 weeks
Secondary Proportion of patients with herapeutic 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 24 weeks
Secondary Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) 48 weeks
Secondary Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir 48 weeks
Secondary Changes from baseline in cholesterol total 24 weeks
Secondary Changes from baseline in cholesterol LDL 24 weeks
Secondary Changes from baseline in cholesterol 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 total 48 weeks
Secondary Changes from baseline in cholesterol LDL 48 weeks
Secondary Changes from baseline in triglycerides 48 weeks
Secondary Changes from baseline in insulin resistance (HOMA-IR) 48 weeks
Secondary Change from baseline in lumbar and femoral bone mineral density 48 weeks
Secondary Change from baseline in plasma 25-OH vitamin D levels 48 weeks
Secondary Change from baseline in urine beta-2-microglobulin 48 weeks
Secondary Change from baseline in estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology CollaborationI) 48 weeks
Secondary Change from baseline in urine protein/creatinine ratio 48 weeks
Secondary Changes from baseline in biomarkers of inflammation IL-6 48 weeks
Secondary Changes from baseline in biomarker of mononuclear activation SD-163 48 weeks
Secondary Changes from baseline in biomarker of mononuclear activation SD-14 48 weeks
Secondary Changes from baseline in biomarker of inflammation high sensitivity C-reactive protein 48 weeks
Secondary Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at 48 weeks
Secondary Change from baseline in EQ-5D-5L 48 weeks
Secondary Incidence of adverse events 48 weeks
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