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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000469-62 | EudraCT Number |
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The aims of this study are to obtain pharmacokinetic data on interactions between dolutegravir (DTG) and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Sirolimus and Mycophenolic acid) in solid organ transplant (SOT) recipients to provide proof of principle data that DTG plus 2 nucleosides (NUCs) is safe and effective in HIV-infected SOT recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-1-infected solid organ transplant patients 1 | Experimental | The patient or donor is not a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is not a carrier of the hepatitis B virus. treatment 48 weeks |
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| HIV-1-infected solid organ transplant patients 2 | Experimental | The patient or donor is a carrier of genetic characteristics that predispose to a severe allergy to Abacavir or the patient is a carrier of the hepatitis B virus. treatment 48 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine 300 MG | Drug | Lamivudine 300 MG/day (48 weeks) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant | Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA) | 24-hours before the switch and 24-hours 2 weeks after switching |
| Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant | Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA). | 24-hours before the switch and 24-hours 2 weeks after switching |
| Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant | 24-hours before the switch and 24-hours 2 weeks after switching |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Resistance | number op patients with VIH viral load > 50 copies/mL virological failure. | week 48 |
| Changes in CD4+ Cell | To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep M MirĂł Meda, MD | Hospital ClĂnico y provincial de Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClĂnic de Barcelona | Barcelona | 08036 | Spain |
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| Label | URL |
|---|---|
| PMCID: PMC12007624 | View source |
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HIV-1-infected adults (>18) with kidney, liver, or heart transplant, on stable ART ≥6 months, HIV RNA <50 c/mL for 12 months, no major resistance mutations, and HLA-B*5701 negative.
Some participants had switched to DTG + 2 NRTIs within the 48 weeks prior to study inclusion, while others switched at the time of enrollment. All participants were followed for 48 weeks from the start of DTG-based ART.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTG + 2 NRTIs | Dolutegravir plus 2 NRTIs in HIV-1-infected solid organ transplant recipients |
| 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 8, 2017 |
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| Abacavir 600 MG | Drug | Abacavir 600 MG/day (48 weeks) |
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| Dolutegravir 50 mg | Drug | Dolutegravir 50 MG/day (48 weeks) |
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| Tenofovir Disoproxil 245Mg Tablet | Drug | Tenofovir 245 MG/day (48 weeks) |
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| Emtricitabine 200 MG | Drug | Emtricitabine 200 MG/day (48 weeks) |
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| week 48 |
| Lipid Profile | To assess the changes in lipid profile (triglycerides) | week 48 |
| Renal Function | To assess creatinine >normal valors mg/dl> 120 mg/dl | week 48 |
| Safety: Number AEs and SAEs | number AEs and SAEs | week 48 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DTG + 2 NRTIs | Dolutegravir plus 2 NRTIs in HIV-1-infected solid organ transplant recipients |
| 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 | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Race and ethnicity data were not collected as part of this study. | 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 | Change in Pharmacokinetic Parameters (Cmax, Cmin) of CsA Immunosuppressant | Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Cyclosporine A (CsA) | Posted | Median | Inter-Quartile Range | ng/mL | 24-hours before the switch and 24-hours 2 weeks after switching |
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| Secondary | Viral Resistance | number op patients with VIH viral load > 50 copies/mL virological failure. | Not Posted | week 48 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in CD4+ Cell | To assess the changes in CD4+ cell count >200 cel/mL in peripheral blood. | Not Posted | week 48 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Lipid Profile | To assess the changes in lipid profile (triglycerides) | Not Posted | week 48 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Renal Function | To assess creatinine >normal valors mg/dl> 120 mg/dl | Not Posted | week 48 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety: Number AEs and SAEs | number AEs and SAEs | Not Posted | week 48 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Pharmacokinetic Parameters (Cmax, Cmin) of MPA Immunosuppressant | Change in pharmacokinetic parameters (Cmax, Cmin) of immunosuppressant Mycophenolic Acid (MPA). | Posted | Median | Inter-Quartile Range | ÎĽg/mL | 24-hours before the switch and 24-hours 2 weeks after switching |
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| Primary | Change in Pharmacokinetic Parameters (Cmax, Cmin) of Tacrolimus Immunosuppressant | Posted | Median | Inter-Quartile Range | ng/mL | 24-hours before the switch and 24-hours 2 weeks after switching |
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Up to 48 weeks of treatment plus 28 days after last dose in case of early withdrawal.
Only adverse events leading to treatment discontinuation or considered clinically relevant are reported individually. All other AEs occurred with low frequency and were not considered related to treatment.
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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 | DTG + 2 NRTIs | Dolutegravir plus 2 NRTIs in HIV-1-infected solid organ transplant recipients | 0 | 19 | 1 | 19 | 15 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytomegalovirus infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment | Unrelated to treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Anxiety symptoms | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Other | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Hyperglycemia | Endocrine disorders | MedDRA 28.0 | Systematic Assessment | With difficult medical control |
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| Diarrhea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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The study was a single-arm pilot trial with a small sample size, which may limit generalizability. The number of participants included in the pharmacokinetic analysis of cyclosporine A was limited, and therefore insufficient to support robust statistical conclusions. No control group was included, and all participants received DTG-based ART. Further studies are needed to confirm findings in larger cohorts.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose M. Miro Meda (PI), MD, PhD, Consultant, Infectious Diseases Service | Hospital ClĂnic/IDIBAPS, University of Barcelona | 93 227 54 30 | JMMIRO@clinic.cat |
| Aug 5, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019259 | Lamivudine |
| C106538 | abacavir |
| C562325 | dolutegravir |
| D000068698 | Tenofovir |
| D013607 | Tablets |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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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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