Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04253119 |
Other study ID # |
VEAP 8370 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.