Phase 3b, single arm, single site simplification study with dual therapy including 3TC (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected atients experiencing inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions with their current regimen. RALAM-II study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000985-31-ES

Enrollment

Registered

2017-09-04

Start date

2017-10-04

Completion date

Unknown

Last updated

2025-03-10

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

Conditions

Virologically suppressed Human Immunodeficiency Virus-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen 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. 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. b. Patients seropositive for HIV-1 using standard diagnostic criteria. c. Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen d. Patients virologically suppressed during at least 12 months prior to inclusion (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. Previous failure to an integrase inhibitor-containing regimen. c. Previous failure to a 3TC or FTC-containing regimen. d. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed. e. 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. f. Chronic hepatitis B.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy assessed with standard plasma HIV-1 RNA detection (limit of detection 5037 copies/mL) at 48 weeks;Secondary Objective: - Change in the reason (inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions) leading to antiretroviral therapy switch - Efficacy assessed with ultrasensitive HIV-1 RNA detection at 48 weeks - Changes in metabolic parameters including fasting plasma lipids and insulin resistance at 48 weeks - Change in estimated glomerular filtration rate, urine protein/creatinine ratio and beta-2-microglobulin at 48 weeks - Change in body fat distribution at 48 weeks - Change in lumbar and femoral bone mineral density at 48 weeks - Changes in immune activation markers including CD38 and HLA-DR at 48 weeks - Changes in biomarkers of inflammation and biomarkers of mononuclear activation at 48 weeks - Change in sleep quality at 48 weeks - Change in quality of life and overall satisfaction at 48 weeks - Overall tolerability at 48 weeks;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 5037 copies/mL) at 48 weeks;Secondary Objective: - Change in the reason (inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions) leading to antiretroviral therapy switch - Efficacy assessed with ultrasensitive HIV-1 RNA detection at 48 weeks - Changes in metabolic parameters including fasting plasma lipids and insulin resistance at 48 weeks - Change in estimated glomerular filtration rate, urine protein/creatinine ratio and beta-2-microglobulin at 48 weeks - Change in body fat distribution at 48 weeks - Change in lumbar and femoral bone mineral density at 48 weeks - Changes in immune activation markers including CD38 and HLA-DR at 48 weeks - Changes in biomarkers of inflammation and biomarkers of mononuclear activation at 48 weeks - Change in sleep quality at 48 weeks - Change in quality of life and overall satisfaction at 48 weeks - Overall tolerability at 48 weeks;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): - Change from baseline in the reason of change of the ARV treatment at 48 weeks. Defined as: changes in quality of life (QoL) calculated by EQ-5D-5L in patients that the reason of switch was inconvenience, Improvement in toxicity in patients that the reason of switch was toxicity or impact on co-morbidities (defined as Changes on Pittsburgh Sleep Quality Index (PSQI) for neurological toxicity, Changes on plasma lipids (cholesterol total, LDL, HDL and triglycerides) on cardiovascular toxicity or co-morbidity, Changes on DXA bone density in skeletal toxicity, Changes on CKD-EPI on kidney toxicity or co-morbidity, Changes proportion of patients that resolve their digestive toxicity: as diarrhea or digestive discomfort) ; changes in the proportion of drug-drug interaction in patients that the reason of switch was drug-drug interactions - Virological failure is defined as two consecutive measurements of plasma viral load above 5037 copies/ml (current detection limit in hospital lab) separated at least by 2 weeks during the assigned treatment, using the FDA snapshot method. - Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks - Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total, LDL, HDL and triglycerides) and insulin resistance (HOMA-IR) at 48 weeks - Changes from baseline in body fat composition at 48 weeks - Changes from baseline in immune activation markers including CD38 and HLA-DR at 48 weeks - 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 EQ-5D-5L quality of life (QoL) and overall satisfaction (VAS) at 48 weeks - Incidence of adverse events;Timepoint(s) of evaluation of this end point: 48 w	—

Measure

Time frame

Secondary end point(s): - Change from baseline in the reason of change of the ARV treatment at 48 weeks. Defined as: changes in quality of life (QoL) calculated by EQ-5D-5L in patients that the reason of switch was inconvenience, Improvement in toxicity in patients that the reason of switch was toxicity or impact on co-morbidities (defined as Changes on Pittsburgh Sleep Quality Index (PSQI) for neurological toxicity, Changes on plasma lipids (cholesterol total, LDL, HDL and triglycerides) on cardiovascular toxicity or co-morbidity, Changes on DXA bone density in skeletal toxicity, Changes on CKD-EPI on kidney toxicity or co-morbidity, Changes proportion of patients that resolve their digestive toxicity: as diarrhea or digestive discomfort) ; changes in the proportion of drug-drug interaction in patients that the reason of switch was drug-drug interactions - Virological failure is defined as two consecutive measurements of plasma viral load above 5037 copies/ml (current detection limit in hospital lab) separated at least by 2 weeks during the assigned treatment, using the FDA snapshot method. - Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks - Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total, LDL, HDL and triglycerides) and insulin resistance (HOMA-IR) at 48 weeks - Changes from baseline in body fat composition at 48 weeks - Changes from baseline in immune activation markers including CD38 and HLA-DR at 48 weeks - 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 EQ-5D-5L quality of life (QoL) and overall satisfaction (VAS) at 48 weeks - Incidence of adverse events;Timepoint(s) of evaluation of this end point: 48 w

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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