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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000986-60 | EudraCT Number |
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| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir + Lamivudine | Experimental | Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Raltegravir (1200 mg QD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Therapeutic Failure | Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir | 48 weeks | |
| Changes From Baseline in Cholesterol Total | 24 weeks | |
| Changes From Baseline in Cholesterol LDL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic i Provincial de Barcelona | Barcelona | 08036 | Spain |
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Selection and baseline will be done in the same visit. Performed at Week 0. During this visit, written informed consent was obtained from each patient, and demographic data, medical history, complete physical examination, and laboratory tests (including hematology, biochemistry, and plasma viral load) were performed to confirm eligibility.
All trial subjects were recruited at a single site in Spain: Hospital ClÃnic de Barcelona. The subjects were patients in the switch arm who completed the 24-week follow-up of RALAM (NCT02284035) study and remained virologically suppressed (viral load <50 copies/mL) on dual therapy with 3TC plus Raltegravir.
Recruitment start period: 02-May-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | RAL+3TC | Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2017 |
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| Lamivudine |
| Drug |
Lamivudine (300 mg QD) |
|
| 24 weeks |
| Changes From Baseline in Cholesterol HDL | 24 weeks |
| Changes From Baseline in Triglycerides | 24 weeks |
| Changes From Baseline in Insulin Resistance (HOMA-IR) | 24 weeks |
| Change From Baseline in Lumbar and Femoral Bone Mineral Density | 48 weeks |
| Change From Baseline in Plasma 25-OH Vitamin D Levels | 48 weeks |
| Change From Baseline in Urine Beta-2-microglobulin | 48 weeks |
| Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI) | 48 weeks |
| Change From Baseline in Urine Protein/Creatinine Ratio | 48 weeks |
| Changes From Baseline in Biomarkers of Inflammation IL-6 | 48 weeks |
| Changes From Baseline in Biomarker of Mononuclear Activation SD-163 | 48 weeks |
| Changes From Baseline in Biomarker of Mononuclear Activation SD-14 | 48 weeks |
| Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein | 48 weeks |
| Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at | 48 weeks |
| Change From Baseline in EQ-5D-5L | 48 weeks |
| Incidence of Adverse Events | 48 weeks |
| Viral Load | Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks | 48 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir + Lamivudine | Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Therapeutic Failure | Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death. | Posted | Count of Participants | Participants | 48 weeks |
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| Secondary | Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Cholesterol Total | Not Posted | 24 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Cholesterol LDL | Not Posted | 24 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Cholesterol HDL | Not Posted | 24 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Triglycerides | Not Posted | 24 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Insulin Resistance (HOMA-IR) | Not Posted | 24 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lumbar and Femoral Bone Mineral Density | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Plasma 25-OH Vitamin D Levels | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urine Beta-2-microglobulin | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI) | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urine Protein/Creatinine Ratio | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Biomarkers of Inflammation IL-6 | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Biomarker of Mononuclear Activation SD-163 | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Biomarker of Mononuclear Activation SD-14 | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EQ-5D-5L | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events | Not Posted | 48 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Viral Load | Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks | Not Posted | 48 weeks | Participants |
48 weeks
Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Raltegravir + Lamivudine | Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) | 0 | 33 | 0 | 33 | 16 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dermatological | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Endocrine | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Infections | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Systemic | General disorders | MedDRA (Unspecified) | Systematic Assessment | Affecting more than ne organ or system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esteban MartÃnez | Hospital Clinic of Barcelona | +34 93 227 54 00 | estebanm@clinic.cat |
| Jun 30, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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