ART First-line Treatment Durability in Russia

Completed

Conditions: HIV-1-infection

Registration Number: NCT04253119

Lead Sponsor: MSD Pharmaceuticals LLC

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 536

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
48 Weeks Treatment Durability	48 weeks	Percentage of patients remained on initial therapy without change of the NNRTI or PI agent

Secondary Outcome Measures

Name	Time	Method
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)
96 Weeks Treatment Durability	96 weeks	Percentage of patients remained on initial therapy without change of the NNRTI or PI agent

Trial Locations

Locations (4): Samara Region AIDS Center
🇷🇺
Samara, Russian Federation
Saint-Petersburg AIDS and Infectious Diseases Center
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Saint Petersburg, Russian Federation
Moscow City AIDS Center of the Moscow Health Department
🇷🇺
Moscow, Russian Federation
Irkutsk Regional AIDS Center
🇷🇺
Irkutsk, Russian Federation