Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of 3TC (150 mg BID) plus Raltegravir (400 mg BID) switching to 3TC (300 mg QD) plus Raltegravir (1200 mg QD) : Roll-over study of the RALAM clinical trial (NCT02284035)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000986-60-ES

Enrollment

Unknown

Registered

2017-08-28

Start date

2017-10-11

Completion date

Unknown

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients of RALAM study (NCT02284035) MedDRA version: 20.0 Level: LLT Classification code 10020445 Term: Human immunodeficiency virus type I infection with constitutional disease System Organ Class: 100000020168

Interventions

Trade Name: Isentress Product Name: Raltegravir Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RALTEGRAVIR CAS Number: 518048-05-0 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: a. Pregnancy, lactation, or planned pregnancy during the study period b. 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 c. Hepatitis B co-infection

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy assessed with standard plasma HIV-1 RNA detection (limit of detection 50 copies/mL) at 48 weeks;Secondary Objective: - efficacy assessed with ultrasensitive HIV-1 RNA detection - change in peripheral mononuclear blood cells HIV-1 reservoir - changes in metabolic parameters including fasting plasma lipids and insulin resistance - change in body fat distribution - change in lumbar and femoral bone mineral density - change in plasma 25-OH vitamin D levels - change in estimated glomerular filtration rate, urine protein/creatinine ratio and urine beta-2-microglobulin - changes in immune activation markers including CD38 and HLA-DR - changes in biomarkers of inflammation and biomarkers of mononuclear activation - change in sleep quality - change in quality of life and overall satisfaction - overall tolerability;Primary end point(s): Therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death.;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Main Objective: Efficacy assessed with standard plasma HIV-1 RNA detection (limit of detection 50 copies/mL) at 48 weeks;Secondary Objective: - efficacy assessed with ultrasensitive HIV-1 RNA detection - change in peripheral mononuclear blood cells HIV-1 reservoir - changes in metabolic parameters including fasting plasma lipids and insulin resistance - change in body fat distribution - change in lumbar and femoral bone mineral density - change in plasma 25-OH vitamin D levels - change in estimated glomerular filtration rate, urine protein/creatinine ratio and urine beta-2-microglobulin - changes in immune activation markers including CD38 and HLA-DR - changes in biomarkers of inflammation and biomarkers of mononuclear activation - change in sleep quality - change in quality of life and overall satisfaction - overall tolerability;Primary end point(s): Therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death.;Timepoint(s) of evaluation of this end point: 48 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - 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 peripheral mononuclear blood cells HIV-1 reservoir to week 48 - Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total, LDL, HDL and triglycerides) and insulin resistance (HOMA-IR) at 48 weeks - Change from baseline in lumbar and femoral bone mineral density to week 48 - Change from baseline in plasma 25-OH vitamin D levels to week 48 - Change from baseline in estimated glomerular filtration rate (CKD-EPI), urine protein/creatinine ratio and urine beta-2-microglobulin to week 48 - Changes from baseline in biomarkers of inflammation (IL-6, high sensitivity C-reactive protein) and biomarkers of mononuclear activation (SD-14, SD-163) at 48 weeks - Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at 48 weeks - Change from baseline in quality of life (QoL) and overall satisfaction (VAS) at 48 weeks - Incidence of adverse events;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Secondary end point(s): - 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 peripheral mononuclear blood cells HIV-1 reservoir to week 48 - Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total, LDL, HDL and triglycerides) and insulin resistance (HOMA-IR) at 48 weeks - Change from baseline in lumbar and femoral bone mineral density to week 48 - Change from baseline in plasma 25-OH vitamin D levels to week 48 - Change from baseline in estimated glomerular filtration rate (CKD-EPI), urine protein/creatinine ratio and urine beta-2-microglobulin to week 48 - Changes from baseline in biomarkers of inflammation (IL-6, high sensitivity C-reactive protein) and biomarkers of mononuclear activation (SD-14, SD-163) at 48 weeks - Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at 48 weeks - Change from baseline in quality of life (QoL) and overall satisfaction (VAS) at 48 weeks - Incidence of adverse events;Timepoint(s) of evaluation of this end point: 48 weeks

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Countries

Spain

Contacts

Public ContactDavid Garcia Cinca

CTU - Clinical Trials Unit

dgarcia@clinic.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026