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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| Saint-Pierre University Hospital | OTHER |
| Agentschap voor Innovatie door Wetenschap en Technologie |
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HIV-1 infected patients with normal peripheral blood CD4+ T-cell counts and undetectable viral load will be recruited in four Belgian HIV reference centers. Selected patients will undergo a two-step screening in which a viral reservoir measurement will be performed and among those with a very low viral reservoir an analytical treatment interruption of their longstanding antiretroviral therapy (ART). There is no randomization foreseen. Patients will receive an intense clinical and laboratory follow-up during 48 weeks followed by 12 weeks post intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment interruption | Experimental | The ART treatment in patients with a very low viral reservoir will be interrupted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ART interruption | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Number of Participants With a HIV Plasma Viral Load Below the Lower Limit of Detection 48 Weeks Following Interruption of Antiretroviral Treatment | The number of post treatment controllers (PTC - i.e. patients under ART at baseline that show low peripheral blood proviral DNA and still will show sustained viral suppression at 48 weeks after treatment interruption) will be determined. The assessment will be based on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. Patients below the lower limit of detection (<50 HIV RNA copies/ml plasma) at 48 weeks after treatment interruption will be considered as PTC. | 48 weeks after treatment interruption |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With and the Severity of Adverse Events That Are Related to the Study Intervention, Graded According to NCI CTCAE Version 4.0 | Confirmation of the safety of a treatment interruption strategy in selected patients will be based on the number and intensity of AEs graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Florence, Dr | Institute of Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Tropical Medicine | Antwerp | 2000 | Belgium | |||
| Saint-Pierre University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32107887 | Derived | Pannus P, Rutsaert S, De Wit S, Allard SD, Vanham G, Cole B, Nescoi C, Aerts J, De Spiegelaere W, Tsoumanis A, Couttenye MM, Herssens N, De Scheerder MA, Vandekerckhove L, Florence E. Rapid viral rebound after analytical treatment interruption in patients with very small HIV reservoir and minimal on-going viral transcription. J Int AIDS Soc. 2020 Feb;23(2):e25453. doi: 10.1002/jia2.25453. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Interruption | The ART treatment in patients with a very low viral reservoir will be interrupted. Phase 1: Screening visit for HIV patients. During this visit a blood sample is taken for HIV reservoir analysis. Patients in which the reservoir is below a certain treshold will continue to phase 2 and will have their ART treatment interrupted (treatment interruption period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
|
| ||||||||||||||||||||||||
| Phase 2 - Treatment Interruption |
|
114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants (Both Phase 1 and 2) | 114 subjects were screened in phase 1. Only those with a low viral reservoir continued to phase 2 (16 subjects). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). |
| 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 | Assessment of the Number of Participants With a HIV Plasma Viral Load Below the Lower Limit of Detection 48 Weeks Following Interruption of Antiretroviral Treatment | The number of post treatment controllers (PTC - i.e. patients under ART at baseline that show low peripheral blood proviral DNA and still will show sustained viral suppression at 48 weeks after treatment interruption) will be determined. The assessment will be based on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. Patients below the lower limit of detection (<50 HIV RNA copies/ml plasma) at 48 weeks after treatment interruption will be considered as PTC. | Analysis population contains all subjects enrolled in phase 2 (treatment interruption phase) | Posted | Count of Participants | Participants | 48 weeks after treatment interruption |
|
Adverse events were collected over the whole study period (from start of treatment interruption until end of follow-up period which was 12 weeks after relapse and treatment restart).
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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 | Treatment Interruption | Subjects enrolled in phase 2 (treatment interruption). There was no AE collection during phase 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Florence | Institute of Tropical Medicine Antwerp | +32 3 247 66 42 | eflorence@itg.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 4, 2018 | May 9, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 23, 2018 | Aug 1, 2019 | Prot_001.pdf |
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| OTHER |
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| 23 months |
| Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Total HIV DNA). | Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of Total HIV DNA. | At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse |
| Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Unspliced RNA). | Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of unspliced RNA. | At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse |
| Assessment of the Kinetics of HIV Viral Load Rebound After Treatment Interruption Based on the Repetitive Plasma Viral Load Measurements. | The kinetics will be on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. A viral load of 19 means <20 copies/mL (lower limit of detection). | At screening, baseline, week 2, week 4, week 6, week 8, End of Intervention (relapse), 4 weeks after relapse and 12 weeks after relapse |
| Brussels |
| 1000 |
| Belgium |
| Brussels University Hospital | Brussels | 1090 | Belgium |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| Subject does not want to participate |
|
| Lost to Follow-up |
|
|
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| Risk group | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| Duration of HIV infection (months) | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | months |
|
| Duration of HIV infection (years) | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | years |
|
| Duration of ART (months) | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | months |
|
| Duration of ART (years) | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | years |
|
| Last used ART | II = Integrase Inhibitor; NRTI = Nucleoside Reverse Transcriptase Inhibitor; NNRTI = Non-Nucleoside Reverse Transcriptase Inhibitor; PI = Protease Inhibitor | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| HIV type | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| Nadir CD4 count | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | cells/µl |
|
| ALT | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | IU/L |
|
| AST | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | IU/L |
|
| Neutrophil count | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | cells/µL |
|
| CD4 count | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | cells/µL |
|
| Creatin | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | mg/dL |
|
| Hemoglobin | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | g/dL |
|
| HCVAb | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | IU/mL |
|
| HBsAb | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| HBcAb | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| HBsAg | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Count of Participants | Participants |
|
| Plasma viral load | A value of 19 means <20 copies/mL (lower limit of detection). | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/mL |
|
| Platelets | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | 10^9 cells/L |
|
| Reservoir CD4 caRNA | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/million CD4+ T-cells |
|
| Ultra-sensitive plasma viral load | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/mL |
|
| Viral reservoir assay DNA | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/10^6PBMCs |
|
| Viral reservoir assay RNA | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/10^6PBMCs |
|
| Spontaneous VRA CD4 | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/mL |
|
| Stimulated VRA CD4 | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/mL |
|
| Spontaneous VRA PBMC | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/mL |
|
| Stimulated VRA PBMC | 114 participants were included in phase 1 of the study. 16 of those continued to phase 2 (treatment interruption). This variable was only tested in those subjects that continued to phase 2 (treatment interruption). | Median | Inter-Quartile Range | copies/mL |
|
The ART treatment in patients with a very low viral reservoir will be interrupted.
ART interruption
|
|
| Secondary | Number of Patients With and the Severity of Adverse Events That Are Related to the Study Intervention, Graded According to NCI CTCAE Version 4.0 | Confirmation of the safety of a treatment interruption strategy in selected patients will be based on the number and intensity of AEs graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). | Population analyzed are the subject enrolled in het treatment interruption phase. | Posted | Count of Participants | Participants | 23 months |
|
|
|
| Secondary | Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Total HIV DNA). | Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of Total HIV DNA. | Population analyzed are the subjects enrolled in phase 2 (treatment interruption). | Posted | Median | Inter-Quartile Range | copies/10^6PBMCs | At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse |
|
|
|
| Secondary | Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Unspliced RNA). | Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of unspliced RNA. | Population analyzed are the subjects enrolled in phase 2 (treatment interruption). | Posted | Median | Inter-Quartile Range | copies/10^6PBMCs | At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse |
|
|
|
| Secondary | Assessment of the Kinetics of HIV Viral Load Rebound After Treatment Interruption Based on the Repetitive Plasma Viral Load Measurements. | The kinetics will be on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. A viral load of 19 means <20 copies/mL (lower limit of detection). | The population analyzed are the subjects enrolled in phase 2 (treatment interruption). | Posted | Median | Inter-Quartile Range | copies/mL | At screening, baseline, week 2, week 4, week 6, week 8, End of Intervention (relapse), 4 weeks after relapse and 12 weeks after relapse |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 13 |
| 16 |
| Faeces soft | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Influenza-like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Vit D deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
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| Other: Colombian |
|
|
| Other: unknown |
|
| Other |
|
| CRF02_AG |
|
|
| No result |
|
| Life-threatening |
|
| No AE |
|
| Influenza-like illness |
|
| Oropharyngeal pain |
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
| Week 6 |
|
| Week 8 |
|
| Post week 12 |
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
| Week 6 |
|
| Week 8 |
|
| Post week 12 |
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
| Week 6 |
|
| Week 8 |
|
| En of Intervention (moment of relapse) |
|
| Post week 4 |
|
| Post week 12 |
|