HIV-1-infection
Conditions
Brief summary
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: * NNRTIs: efavirenz (EFV), nevirapine (NVP), rilpivirine (RPV), ETR (etravirine) * PIs: LPV (lopinavir), DRV (darunavir), ATV (atazanavir), FPV (fosamprenavir)
Detailed description
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.
Interventions
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
Sponsors
MSD Pharmaceuticals LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years of age) with definite HIV-1 infection based on positive lab test and judgement of treating physician according to standards of care * Naive to antiretroviral treatment at the time of initiation * Viral load of \>1000 copies/ml at the time of initiation of ART * Initiated their first-line ART between February 01 and April 30, 2017 * Patients are included, if the third component of their first line ART was either NNRTI or boosted PI plus NRTIs * Completed follow-up from baseline for at least 96 weeks * Signed informed consent
Exclusion criteria
• HIV-2 infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 48 Weeks Treatment Durability | 48 weeks | Percentage of patients remained on initial therapy without change of the NNRTI or PI agent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 96 Weeks Treatment Durability | 96 weeks | Percentage of patients remained on initial therapy without change of the NNRTI or PI agent |
| Time on Therapy at 48 Weeks | 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 on Therapy at 96 Weeks | 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) |
Countries
Russia
Participant flow
Recruitment details
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.
Pre-assignment details
536 subjects were enrolled instead of planned 1000 participants due to slow recruitment because of COVID-19 pandemia. This protocol deviation was documented accordingly.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 536 |
| Total | 536 |
Baseline characteristics
| Characteristic | Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | — |
|---|---|---|
| Age, Customized 40 - 60 years | 187 Participants | — |
| Age, Customized < 40 years | 338 Participants | — |
| Age, Customized > 60 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 536 Participants | — |
| Sex: Female, Male Female | 217 Participants | — |
| Sex: Female, Male Male | 319 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 536 |
| other Total, other adverse events | 0 / 536 |
| serious Total, serious adverse events | 0 / 536 |
Outcome results
Primary
48 Weeks Treatment Durability
Percentage of patients remained on initial therapy without change of the NNRTI or PI agent
Time frame: 48 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | 48 Weeks Treatment Durability | 76.0 percentage of participants |
Secondary
96 Weeks Treatment Durability
Percentage of patients remained on initial therapy without change of the NNRTI or PI agent
Time frame: 96 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | 96 Weeks Treatment Durability | 60.3 percentage of participants |
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)
Time frame: 48 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | Time on Therapy at 48 Weeks | 46.8 weeks | Standard Deviation 15.1 |
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)
Time frame: 96 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. | Time on Therapy at 96 Weeks | 78.8 weeks | Standard Deviation 33.8 |