Trial Outcomes & Findings for ART First-line Treatment Durability in Russia (NCT NCT04253119)

Results Overview

Percentage of patients remained on initial therapy without change of the NNRTI or PI agent

Recruitment status

COMPLETED

Target enrollment

536 participants

Primary outcome timeframe

48 weeks

Results posted on

2024-04-17

Participant Flow

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.

536 subjects were enrolled instead of planned 1000 participants due to slow recruitment because of COVID-19 pandemia. This protocol deviation was documented accordingly.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	536
Overall Study COMPLETED	536
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. n=536 Participants 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.
Age, Customized < 40 years	338 Participants n=536 Participants
Age, Customized 40 - 60 years	187 Participants n=536 Participants
Age, Customized > 60 years	11 Participants n=536 Participants
Sex: Female, Male Female	217 Participants n=536 Participants
Sex: Female, Male Male	319 Participants n=536 Participants
Region of Enrollment Russia	536 Participants n=536 Participants

PRIMARY outcome

Timeframe: 48 weeks

Percentage of patients remained on initial therapy without change of the NNRTI or PI agent

Outcome measures

Outcome measures
Measure	Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. n=536 Participants 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.
48 Weeks Treatment Durability	76.0 percentage of participants Interval 72.2 to 79.6

SECONDARY outcome

Timeframe: 96 weeks

Percentage of patients remained on initial therapy without change of the NNRTI or PI agent

Outcome measures

Outcome measures
Measure	Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. n=536 Participants 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.
96 Weeks Treatment Durability	60.3 percentage of participants Interval 56.0 to 64.4

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. n=536 Participants 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.
Time on Therapy at 48 Weeks	46.8 weeks Standard Deviation 15.1

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care. n=536 Participants 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.
Time on Therapy at 96 Weeks	78.8 weeks Standard Deviation 33.8

Adverse Events

Treatment-naive at the Time of Initiation of ART Per the Usual Standard of Care.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vladimir Achikyan, Medical Affairs Manager

MSD Pharmaceuticals LLC

Phone: 79161981264

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER