ART First-line Treatment Durability in Russia

HIV-1-infection Clinical Trial

Official title:

Retrospective Evaluation of Treatment Durability Among Treatment-naive HIV-infected Individuals Initiated First-line ART in Russia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253119
• Other study ID #: VEAP 8370
• Status: Completed
• Start date: November 26, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2024
• Source: MSD Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Antiretroviral/Anti HIV
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

Locations

Country	Name	City	State
Russian Federation	Irkutsk Regional AIDS Center	Irkutsk
Russian Federation	Moscow City AIDS Center of the Moscow Health Department	Moscow
Russian Federation	Saint-Petersburg AIDS and Infectious Diseases Center	Saint Petersburg
Russian Federation	Samara Region AIDS Center	Samara

Sponsors (1)

Lead Sponsor	Collaborator
MSD Pharmaceuticals LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	48 Weeks Treatment Durability	Percentage of patients remained on initial therapy without change of the NNRTI or PI agent	48 weeks
Secondary	96 Weeks Treatment Durability	Percentage of patients remained on initial therapy without change of the NNRTI or PI agent	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)	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)	96 weeks