Phase 3
Completed N=33
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
Source: ClinicalTrials.gov NCT03311945 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Proportion of Patients With Therapeutic Failure — 3; 30 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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)
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 |
— | — |
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
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. Informational only — not medical advice.