An observational study in HIV-1-infection, sponsored by MSD Pharmaceuticals LLC. Completed at 4 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by MSD Pharmaceuticals LLC · Observational
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.
MSD Pharmaceuticals LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
48 Weeks Treatment Durability
Percentage of patients remained on initial therapy without change of the NNRTI or PI agent
Time frame: 48 weeks
96 Weeks Treatment Durability
Percentage of patients remained on initial therapy without change of the NNRTI or PI agent
Time frame: 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)
Time frame: 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)
Time frame: 96 weeks
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.
| Milestone | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| Started | 536 |
| Completed | 536 |
| Not completed | 0 |
Percentage of patients remained on initial therapy without change of the NNRTI or PI agent
| percentage of participants | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| 48 Weeks Treatment Durability | 76.0 (72.2 to 79.6) |
Percentage of patients remained on initial therapy without change of the NNRTI or PI agent
| percentage of participants | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| 96 Weeks Treatment Durability | 60.3 (56.0 to 64.4) |
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)
| weeks | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| Time on Therapy at 48 Weeks | 46.8 ± 15.1 |
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)
| weeks | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| Time on Therapy at 96 Weeks | 78.8 ± 33.8 |
Collected over Up to 78 weeks (November 2019 - April 2021). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | 0/536 (0%) | 0/536 (0%) | 0/536 (0%) |
| Age, Customized(Participants) | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| < 40 years | 338 |
| 40 - 60 years | 187 |
| > 60 years | 11 |
| Sex: Female, Male(Participants) | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| Female | 217 |
| Male | 319 |
| Race and Ethnicity Not Collected(Participants) | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|
| Region of Enrollment(Participants) | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. |
|---|---|
| Russia | 536 |
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Plan to share: No
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MSD Pharmaceuticals LLC