A Clinical Trial to Study the Safety and Efficacy of TLE-400mg Vs TLE-600mg in Indian Patients with HIV-1 Infection.

Multicenter, Open-Label, Randomized, Prospective Phase IV, Interventional, Non-Inferiority Study with Blinded Assessment, to Evaluate the Efficacy and Safety of Fixed Dose Combination (FDC) of Tenofovir/Lamivudine/Low Dose Efavirenz (300/300/400mg) Vs Tenofovir/Lamivudine/Low Dose Efavirenz (300/300/600mg) in Adult Indian Patients with HIV-1 Infection.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010679

Enrollment

250

Registered

2017-11-28

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: - Health Condition 2: null- HIV-1 infection

Interventions

Intervention1: Tenofovir/ Lamivudine/Efavirenz: 300/300/400 mg Oral Tablet 24 weeks Control Intervention1: Tenofovir/ Lamivudine/Efavirenz: 300/300/600 mg Oral Tablet 24 Weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. To provide written informed consent. 2. BMI >= 18 kg/m2. 3. Confirmed HIV-1 infection. 4. Plasma HIV-1 viral load of at least 1000 copies per mL. 5. For females of childbearing potential, a negative serum pregnancy.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing female. 2. Previous AIDS defining illness. 3. Any uncontrolled opportunistic infection or malignancy. 4. Absolute neutrophil counts lower than 500 cells per Î¼L. 5. Platelet count lower than 50,000 cells per Î¼L. 6. Serum transaminases more than five-times the upper limit of normal. 7. Subjects with Hemoglobin >= 7 g/dL or 4.34 mmol/L. 8. Subjects with renal impairment (eGFR 9. Subjects on medicinal products contraindicated to use Tenofovir, Lamivudine and Efavirenz. 10. Patient having history of clinically-significant illness or any other major medical disorder. 11. History of GI disorder that interferes with metabolism. 12. Patients with known hypersensitivity to the investigational product. 13. Subject is unable to follow study instructions or comply with procedures involved as per protocol. 14. Any other condition as per the physicianâ??s discretion that would make the subject ineligible for the study.

Design outcomes

Primary

Measure	Time frame
Difference in proportion of subjects with Plasma HIV-1 RNA of less than 200 copies/mL between the treatment groups at the end of treatmentTimepoint: Week 24	—

Secondary

Measure	Time frame
Incidence of adverse events. Mean change in the CD4 cell count in the two study arms. Exploratory-CYP2B6 polymorphism and PK profile of Efavirenz.Timepoint: All Weeks Week 24 Day 1	—

Countries

India

Contacts

Public ContactDr Rajesh Nachankar

Mylan Pharmaceuticals Pvt Limited

sanjeev.hegde@mylan.com7349635726

Outcome results

None listed

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