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This study is a non-interventional retrospective study. Data from patients who signed informed consent form will be collected through retrospective chart or medical records review. Patients have been receiving treatment and diagnostic procedures according to daily clinical practice conducted by his/her physician. There are no procedures that are required as part of this study.
The study is to be conducted in 6 investigational sites across Russia with up to 200 patients recruited per site.
HIV-infected patients with no experience of therapy at time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs will be enrolled and followed retrospectively for up to 96 weeks with data collection at the approximate time points of baseline (pre-treatment) and at 48 and 96 weeks after start of treatment.
The following ARV drugs are considered according to the standards of care:
All patients must have initiated ART between February 01 and April 30, 2017. A time window for the retrospective visits at baseline, 48 and 96 weeks is envisaged as approximately ± 8 weeks.
Patients will be retrospectively screened and selected according to inclusion and exclusion criteria prior to enrollment in each investigational site starting the day of its initiation. The study sites will maintain a list of all screened patients. All patients eligible according to the inclusion/exclusion criteria and after signing the informed consent form are to be consequently enrolled for their demographic and clinical data collection through retrospective chart or medical records review. The enrollment will continue until the recruitment goal is reached.
Baseline and follow-up data will be extracted through retrospective chart or medical records review, if available at each investigational site. No additional interventional testsor medical procedures such as additional blood samples, X-ray or other technical investigations will be performed as a part of this study. If any data element is not available, it will be reported as missing.
At baseline, demographic and clinical data on age, gender, employment status, marital status, substance abuse, HIV diagnosis duration, route of infection, AIDS stage, viral load, CD4 count, concomitant medication, comorbidities (noted diagnosis by physician) are to be collected through retrospective chart or medical records review.
At 48 and 96 weeks of retrospective follow-up, the investigators will assess through the medical records whether the patient was still on treatment with initiated ART (NNRTI, PI) and evaluate the estimated time on therapy without change of the NNRTI or PI agent within the class or without change of the NNRTI or PI agent to a different class.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiretroviral/Anti HIV | Drug | NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs per the usual standard of care of the investigator in AIDS clinics of Russia |
| Measure | Description | Time Frame |
|---|---|---|
| 48 Weeks Treatment Durability | Percentage of patients remained on initial therapy without change of the NNRTI or PI agent | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 96 Weeks Treatment Durability | Percentage of patients remained on initial therapy without change of the NNRTI or PI agent | 96 weeks |
| Time on Therapy at 48 Weeks | Estimated time on therapy without change of the NNRTI or PI agent at 48 weeks among treatment naive HIV-infected individuals initiated ART (NNRTI, PI) |
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Inclusion Criteria:
Exclusion Criteria:
• HIV-2 infection
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All patients enrolled must be treatment naive at the time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs per the usual standard of care of the investigator in AIDS clinics of Russia.
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Lukyanova, MD | MSD Pharmaceuticals LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irkutsk Regional AIDS Center | Irkutsk | Russia | ||||
| Moscow City AIDS Center of the Moscow Health Department |
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536 subjects were enrolled instead of planned 1000 participants due to slow recruitment because of COVID-19 pandemia. This protocol deviation was documented accordingly.
The study was conducted in investigational sites across Russia with up to 200 patients recruited per site. Each investigational site will be a dedicated HIV clinic or an HIV department in clinic of infectious diseases. It is planned that the first half of the study population (500 patients) will be enrolled during the first 6-9 months and the second half of the study population (500 patients) during the second 6-9 months of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | HIV-infected patients with no experience of therapy at time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs will be enrolled and followed retrospectively for up to 96 weeks with data collection at the approximate time points of baseline (pre-treatment) and at 48 and 96 weeks after start of treatment of the investigator in AIDS clinics of Russia. All patients must have initiated ART between February 01 and June 30, 2017. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | HIV-infected patients with no experience of therapy at time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs will be enrolled and followed retrospectively for up to 96 weeks with data collection at the approximate time points of baseline (pre-treatment) and at 48 and 96 weeks after start of treatment of the investigator in AIDS clinics of Russia. All patients must have initiated ART between February 01 and June 30, 2017. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | 48 Weeks Treatment Durability | Percentage of patients remained on initial therapy without change of the NNRTI or PI agent | Posted | Number | 95% Confidence Interval | percentage of participants | 48 weeks |
|
Up to 78 weeks (November 2019 - April 2021)
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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-naive at the Time of Initiation of ART Per the Usual Standard of Care. | HIV-infected patients with no experience of therapy at time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs will be enrolled and followed retrospectively for up to 96 weeks with data collection at the approximate time points of baseline (pre-treatment) and at 48 and 96 weeks after start of treatment of the investigator in AIDS clinics of Russia. All patients must have initiated ART between February 01 and June 30, 2017. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Achikyan, Medical Affairs Manager | MSD Pharmaceuticals LLC | 79161981264 | vladimir.achikyan@merck.com |
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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 | Jul 2, 2020 | Oct 6, 2022 | Prot_SAP_000.pdf |
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| 48 weeks |
| Time on Therapy at 96 Weeks | Estimated time on therapy without change of the NNRTI or PI agent at 96 weeks among treatment naive HIV-infected individuals initiated ART (NNRTI, PI) | 96 weeks |
| Moscow |
| Russia |
| Saint-Petersburg AIDS and Infectious Diseases Center | Saint Petersburg | Russia |
| Samara Region AIDS Center | Samara | Russia |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 96 Weeks Treatment Durability | Percentage of patients remained on initial therapy without change of the NNRTI or PI agent | Posted | Number | 95% Confidence Interval | percentage of participants | 96 weeks |
|
|
|
| Secondary | Time on Therapy at 48 Weeks | Estimated time on therapy without change of the NNRTI or PI agent at 48 weeks among treatment naive HIV-infected individuals initiated ART (NNRTI, PI) | Posted | Mean | Standard Deviation | weeks | 48 weeks |
|
|
|
| Secondary | Time on Therapy at 96 Weeks | Estimated time on therapy without change of the NNRTI or PI agent at 96 weeks among treatment naive HIV-infected individuals initiated ART (NNRTI, PI) | Posted | Mean | Standard Deviation | weeks | 96 weeks |
|
|
|
| 0 |
| 536 |
| 0 |
| 536 |
| 0 |
| 536 |
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