CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 536 enrolled
Drug / intervention
Antiretroviral/Anti HIVdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04253119
NCT04253119N/ACompleted

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

MSD Pharmaceuticals LLC·observational·Posted Feb 5, 2020·Updated Apr 17, 2024

In Brief

An observational study evaluating Antiretroviral/Anti HIV for HIV-1-infection. Completed, enrolled 536 participants across 4 sites.

Detailed 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)

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesRussia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 5, 2020
Enrollment StartNov 26, 2019
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.4 years ago

Interventions

Antiretroviral/Anti HIVdrug

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