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Observational study to assess compliance, safety issues and treatment response to single pill once daily regimen of Tenofovir, Lamivudine, Efavirenz (TLE) in HIV infected adult patients

An observational study to assess medication adherence, safety profile and treatment response to fixed dose combination of Tenofovir, Lamivudine, Efavirenz (TLE) in HIV infected adult patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/03/006742
Enrollment
150
Registered
2016-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- HIV patients receiving ART

Interventions

None listed

Sponsors

Department of Pharmacology IPGMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. All HIV infected adult patients (age >18 years) of either gender attending and registered to ART centre of SSKM hospital. ii. HIV infected adult patients being initiated on fixed dose combination TLE regimen or those who are being shifted to fixed dose combination TLE regimen from other ART regimens (e.g. TL+N or ZL+E or ZL+N). iii. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: i. Patients who are on ART regimens other than TLE. ii. Patients being shifted to TL+E only due to concomitant Anti Tubercular Drug administration

Design outcomes

Primary

MeasureTime frame
1. To assess medication adherence to fixed dose combination of TLE regimen. 2. To monitor the safety profile of this regimen. Timepoint: The study is intended to be completed within a period of eighteen months from inception. The recruitment e completed within a period of 9 months. Each enrolled subject will be followed up for a period of 6 months.—

Secondary

MeasureTime frame
1. To identify the contributory factors for sub-optimal medication adherence. 2. To assess the treatment response to this regimen.Timepoint: The study is intended to be completed within a period of eighteen months from inception. The recruitment e completed within a period of 9 months. Each enrolled subject will be followed up for a period of 6 months.—

Countries

India

Contacts

Public ContactAMRITENDU MANDAL
drsupchat@gmail.com09831130980

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026