Phase 3
Completed N=74
Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
Source: ClinicalTrials.gov NCT02284035 ↗Enrolled (actual)
74
Serious AEs
8.1%
Results posted
Jul 2025
Primary outcomePrimary: Proportion of Patients Free of Therapeutic Failure — 47; 20; 0; 2 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 This can indicate results are unpublished — a known publication-bias signal.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
A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Free of Therapeutic Failure |
47; 20; 0; 2; 1; 0 | — |
| SECONDARY Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL) |
— | — |
| SECONDARY Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir |
— | — |
| SECONDARY Changes in Insulin Resistance (HOMA-IR) |
— | — |
| SECONDARY Changes in Body Fat Composition |
54.13; 49.43; 28.50; 27.54; 54.09; 50.21 | — |
| SECONDARY Changes in Plasma 25-OH Vitamin D Levels |
17.4; 16.7; 29.5; 26.5 | — |
| SECONDARY Changes in Estimated Glomerular Filtration Rate (CKD-EPI) |
— | — |
| SECONDARY Changes in CD38 |
— | — |
| SECONDARY Changes in IL-6 |
— | — |
| SECONDARY Changes in Sleep Quality (Pittsburgh Sleep Quality Index) |
5; 4.7; 4.8; 5.1 | — |
| SECONDARY Changes in Adherence in Both Treatment Arms (Morisky-Green Test) |
19; 11; 29; 13; 1; 1 | — |
| SECONDARY Changes in Total Cholesterol |
189; 187; 190; 186 | — |
| SECONDARY Changes in HDL Cholesterol |
48; 46; 49; 45 | — |
| SECONDARY Changes in LDL Cholesterol |
120; 115; 119; 118 | — |
| SECONDARY Changes in Triglycerides |
98.5; 112.0; 97.7; 100.9 | — |
| SECONDARY Changes in Bone Mineral Density |
1166.1; 1211.6; 1183.0; 1247.4 | — |
| SECONDARY Changes in Urine Beta-2-microglobulin/Creatinine Ratio |
672.8; 595.3; 275.7; 788.5 | — |
| SECONDARY Changes in HLA-DR |
— | — |
| SECONDARY Changes in High Sensitivity C-reactive Protein |
— | — |
| SECONDARY Changes in Mononuclear Activation SD-14 |
— | — |
| SECONDARY Changes in Mononuclear Activation SD-163 |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Patients seropositive for HIV-1 using standard diagnostic criteria.
- Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
- Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
- Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
- Patients who have signed informed consent to participate in the study.
Exclusion Criteria
- Pregnancy, lactation, or planned pregnancy during the study period.
- Previous failure to an integrase inhibitor-containing regimen.
- Previous failure to a 3TC or FTC-containing regimen.
- Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
- 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.
- Chronic hepatitis B.
Data sourced from ClinicalTrials.gov (NCT02284035). 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.