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ART First-line Treatment Durability in Russia

NCT04253119 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 536

Last updated 2024-04-17

Study results available
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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)

Conditions

Interventions

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

Sponsors & Collaborators

  • MSD Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Ekaterina Lukyanova, MD · MSD Pharmaceuticals LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253119 on ClinicalTrials.gov