Phase 3 N=33 Treatment

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

HIV Infections · HIV-1-infection · HIV Seropositivity

Bottom Line

View on ClinicalTrials.gov: NCT03311945 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Proportion of Patients With Therapeutic Failure — 3; 30 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Raltegravir (Drug); Lamivudine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Judit Pich
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients With Therapeutic Failure	3; 30	—
SECONDARY Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir	—	—
SECONDARY Changes From Baseline in Cholesterol Total	—	—
SECONDARY Changes From Baseline in Cholesterol LDL	—	—
SECONDARY Changes From Baseline in Cholesterol HDL	—	—
SECONDARY Changes From Baseline in Triglycerides	—	—
SECONDARY Changes From Baseline in Insulin Resistance (HOMA-IR)	—	—
SECONDARY Change From Baseline in Lumbar and Femoral Bone Mineral Density	—	—
SECONDARY Change From Baseline in Plasma 25-OH Vitamin D Levels	—	—
SECONDARY Change From Baseline in Urine Beta-2-microglobulin	—	—
SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI)	—	—
SECONDARY Change From Baseline in Urine Protein/Creatinine Ratio	—	—
SECONDARY Changes From Baseline in Biomarkers of Inflammation IL-6	—	—
SECONDARY Changes From Baseline in Biomarker of Mononuclear Activation SD-163	—	—
SECONDARY Changes From Baseline in Biomarker of Mononuclear Activation SD-14	—	—
SECONDARY Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein	—	—
SECONDARY Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at	—	—
SECONDARY Change From Baseline in EQ-5D-5L	—	—
SECONDARY Incidence of Adverse Events	—	—
SECONDARY Viral Load	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03311945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.