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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003142-27 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Raltegravir / 3TC (MK0518B | Experimental | Raltegravir / 3TC (MK0518B ) (50 patients) |
|
| Group 2 standard combination therapy | Active Comparator | NNRTI-Based Regimen: • EFV/TDF/FTC PI-Based Regimens: ATV/r + TDF/FTC or DRV/r + TDF/FTC INSTI-Based Regimens: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC NNRTI-Based Regimens: EFV plus ABC/3TC or RPV/TDF/FTC PI-Based Regimen: ATV/r plus ABC/3TC PI-Based Regimens: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC INSTI-Based Regimen: RAL plus ABC/3TC And other ART regimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir/3TC | Drug | MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Free of Therapeutic Failure | Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL) | 24 weeks | |
| Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esteban Martinez, MD PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | 08036 | Spain |
A total of 75 participants were enrolled and randomized. One participant assigned to the Raltegravir/Lamivudine arm withdrew consent before starting treatment and was excluded from the analysis. As a result, 74 participants initiated treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Raltegravir / 3TC (MK0518B) | Raltegravir / 3TC (MK0518B ) Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. |
| FG001 | Group 2 Standard Combination Therapy |
| 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 | Nov 7, 2014 |
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| EFV/TDF/FTC | Drug | standard combination therapy |
|
|
| ATV/r + TDF/FTC or DRV/r + TDF/FTC | Drug |
|
|
| DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC | Drug |
|
|
| EFV plus ABC/3TC or RPV/TDF/FTC | Drug |
|
|
| ATV/r plus ABC/3TC | Drug |
|
|
| DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC | Drug |
|
|
| RAL plus ABC/3TC | Drug |
|
|
| Other ART regimens | Drug |
|
| Changes in Insulin Resistance (HOMA-IR) | Composite measure | 24 weeks |
| Changes in Body Fat Composition | Composite measure | 24 weeks |
| Changes in Plasma 25-OH Vitamin D Levels | 24 weeks |
| Changes in Estimated Glomerular Filtration Rate (CKD-EPI) | Composite measure | 24 weeks |
| Changes in CD38 | 24 weeks |
| Changes in IL-6 | 24 weeks |
| Changes in Sleep Quality (Pittsburgh Sleep Quality Index) | The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality. | 24 weeks |
| Changes in Adherence in Both Treatment Arms (Morisky-Green Test) | Patients were asked to complete the Morisky-Green questionnaire: Some people forget to take their medication as prescribed. How often does it happen to you? (Always/often/sometimes/rarely/never) Some people forget some taking of the medication or change the prescribed schedule / take to adapt it to their own needs. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel better. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel worse. How often do you do it? (Always/often/sometimes/rarely/never) Only if patients answered never to each four questions, they were considered adherent; if not, non adherent. | 24 weeks |
| Changes in Total Cholesterol | 24 weeks |
| Changes in HDL Cholesterol | 24 weeks |
| Changes in LDL Cholesterol | 24 weeks |
| Changes in Triglycerides | 24 weeks |
| Changes in Bone Mineral Density | DEXA | 24 weeks |
| Changes in Urine Beta-2-microglobulin/Creatinine Ratio | 24 weeks |
| Changes in HLA-DR | 24 weeks |
| Changes in High Sensitivity C-reactive Protein | 24 weeks |
| Changes in Mononuclear Activation SD-14 | 24 weeks |
| Changes in Mononuclear Activation SD-163 | 24 weeks |
NNRTI-Based Regimen: • EFV/TDF/FTC PI-Based Regimens: ATV/r + TDF/FTC or DRV/r + TDF/FTC INSTI-Based Regimens: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC NNRTI-Based Regimens: EFV plus ABC/3TC or RPV/TDF/FTC PI-Based Regimen: ATV/r plus ABC/3TC PI-Based Regimens: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC INSTI-Based Regimen: RAL plus ABC/3TC And other ART regimens EFV/TDF/FTC: standard combination therapy ATV/r + TDF/FTC or DRV/r + TDF/FTC DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC EFV plus ABC/3TC or RPV/TDF/FTC ATV/r plus ABC/3TC DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC RAL plus ABC/3TC Other ART regimens |
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline measures are reported for the 74 participants who initiated treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Raltegravir / 3TC (MK0518B) | Raltegravir / 3TC (MK0518B ) Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. |
| BG001 | Group 2 Standard Combination Therapy | NNRTI-Based Regimen: • EFV/TDF/FTC PI-Based Regimens: ATV/r + TDF/FTC or DRV/r + TDF/FTC INSTI-Based Regimens: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC NNRTI-Based Regimens: EFV plus ABC/3TC or RPV/TDF/FTC PI-Based Regimen: ATV/r plus ABC/3TC PI-Based Regimens: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC INSTI-Based Regimen: RAL plus ABC/3TC And other ART regimens EFV/TDF/FTC: standard combination therapy ATV/r + TDF/FTC or DRV/r + TDF/FTC DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC EFV plus ABC/3TC or RPV/TDF/FTC ATV/r plus ABC/3TC DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC RAL plus ABC/3TC Other ART regimens |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 Free of Therapeutic Failure | Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death | A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit. | Posted | Count of Participants | Participants | 24 weeks |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL) | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Insulin Resistance (HOMA-IR) | Composite measure | Not Posted | 24 weeks | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Body Fat Composition | Composite measure | Some patients were not performed a DEXA during the study | Posted | Mean | Standard Deviation | percentage of fat weight | 24 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Changes in Plasma 25-OH Vitamin D Levels | Some patients vitamine D determination was not available | Posted | Mean | Standard Deviation | ng/mL | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in Estimated Glomerular Filtration Rate (CKD-EPI) | Composite measure | Not Posted | 24 weeks | Participants | ||||||||||||||||||||||||||||||||||||
| Secondary | Changes in CD38 | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in IL-6 | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Sleep Quality (Pittsburgh Sleep Quality Index) | The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality. | Some patients did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in Adherence in Both Treatment Arms (Morisky-Green Test) | Patients were asked to complete the Morisky-Green questionnaire: Some people forget to take their medication as prescribed. How often does it happen to you? (Always/often/sometimes/rarely/never) Some people forget some taking of the medication or change the prescribed schedule / take to adapt it to their own needs. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel better. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel worse. How often do you do it? (Always/often/sometimes/rarely/never) Only if patients answered never to each four questions, they were considered adherent; if not, non adherent. | Some patients did not complete the questionnaire | Posted | Count of Participants | Participants | 24 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Changes in Total Cholesterol | Some patients have not performed all the protocol determinations | Posted | Mean | Standard Deviation | mg/dl | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in HDL Cholesterol | Some patients did not performed all the determinations | Posted | Mean | Standard Deviation | mg/dl | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in LDL Cholesterol | Some patients did not perform all the determinations | Posted | Mean | Standard Deviation | mg/dl | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in Triglycerides | All patients did not perform all the determinations | Posted | Mean | Standard Deviation | mg/dl | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in Bone Mineral Density | DEXA | Not all the patients performed the DEXA | Posted | Mean | Standard Deviation | gr/cm^2 | 24 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Changes in Urine Beta-2-microglobulin/Creatinine Ratio | Some patients did not performed this determination | Posted | Mean | Standard Deviation | mg/g | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Changes in HLA-DR | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in High Sensitivity C-reactive Protein | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Mononuclear Activation SD-14 | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Mononuclear Activation SD-163 | Not Posted | 24 weeks | Participants |
6 months
An adverse event (AE) is any untoward occurrence to the health of a patient or clinical trial subject treated with a medicinal product and which does not necessarily have a causal relationship with this treatment.
A total of 75 subjects were randomized. However, in the RAL/3TC group (n=50), one subject was excluded due to consent withdrawal prior to the initiation of medication and therefore did not complete the Baseline (randomization) visit.
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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 | Group 1 Raltegravir / 3TC (MK0518B) | Raltegravir / 3TC (MK0518B ) (50 patients) Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. | 1 | 49 | 3 | 49 | 12 | 49 |
| EG001 | Group 2 Standard Combination Therapy | NNRTI-Based Regimen: • EFV/TDF/FTC PI-Based Regimens: ATV/r + TDF/FTC or DRV/r + TDF/FTC INSTI-Based Regimens: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC NNRTI-Based Regimens: EFV plus ABC/3TC or RPV/TDF/FTC PI-Based Regimen: ATV/r plus ABC/3TC PI-Based Regimens: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC INSTI-Based Regimen: RAL plus ABC/3TC And other ART regimens EFV/TDF/FTC: standard combination therapy ATV/r + TDF/FTC or DRV/r + TDF/FTC DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC EFV plus ABC/3TC or RPV/TDF/FTC ATV/r plus ABC/3TC DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC RAL plus ABC/3TC Other ART regimens | 0 | 25 | 3 | 25 | 10 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered blood test | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | On May 30, 2016 goes to the emergency room. In the analysis we can see elevation of ldh, ck, anemia and thrombocytopenia not present in previous analyzes so it is admitted for study. |
|
| Prostate Neoplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | Patient with well-controlled hiv infection. Suspected prostate neoplasia (biopsy due to thrombocytopenia) with bone metastasis, metastatic medullary infiltration |
|
| hilar adenopathies and anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | hilar adenopathies and anemia |
|
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | disseminated melanoma |
|
| Hernia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | umbilical hernia, inguinal hernia |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| febrile syndrome | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | 3-day course of diarrhea |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amigdalitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ansiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lues | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dizziness | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Sickness or emesis |
|
| Common cold | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Esteban Martínez | Hospital Clinic of Barcelona | +34 93 227 54 00 | ESTEBANM@clinic.cat |
| May 21, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
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| ID | Term |
|---|---|
| C098320 | efavirenz |
Not provided
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Pregnancy |
|
| Stops treatment |
|
| Virological faiulure |
|
| Stops study medical decision |
|
| Counts |
|---|
| Participants |
|
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| Participants |
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
| Not evaluated/ Lost follow Up |
|