N/A
N=536
ART First-line Treatment Durability in Russia
HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT04253119 ↗Enrolled (actual)
536
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: 48 Weeks Treatment Durability — 76.0 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Antiretroviral/Anti HIV (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MSD Pharmaceuticals LLC
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 48 Weeks Treatment Durability |
76.0 | — |
| SECONDARY 96 Weeks Treatment Durability |
60.3 | — |
| SECONDARY Time on Therapy at 48 Weeks |
46.8 | — |
| SECONDARY Time on Therapy at 96 Weeks |
78.8 | — |
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)
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
Data sourced from ClinicalTrials.gov (NCT04253119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.