Clinical trial NCT04253119: ART First-line Treatment Durability in Russia
Official title: Retrospective Evaluation of Treatment Durability Among Treatment-naive HIV-infected Individuals Initiated First-line ART in Russia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Lead sponsor: MSD Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 48 Weeks Treatment Durability
timeFrame: 48 weeks
Secondary outcomes:
measure: 96 Weeks Treatment Durability
timeFrame: 96 weeks
measure: Time on Therapy at 48 Weeks
timeFrame: 48 weeks
measure: Time on Therapy at 96 Weeks
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional AIDS Center
city: Moscow
country: Russian Federation
facility: Moscow City AIDS Center of the Moscow Health Department
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg AIDS and Infectious Diseases Center
city: Samara
country: Russian Federation
facility: Samara Region AIDS Center
Study officials:
affiliation: MSD Pharmaceuticals LLC
name: Ekaterina Lukyanova, MD
role: STUDY_DIRECTOR
References: