A Clinical Trial to Study the Safety and Efficacy of TLE-400mg Vs TLE-600mg in Indian Patients with HIV-1 Infection.
- Conditions
- Health Condition 1: - Health Condition 2: null- HIV-1 infection
- Registration Number
- CTRI/2017/11/010679
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 265
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.
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 μL.
5. Platelet count lower than 50,000 cells per μL.
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 <50 mL/min/1.73 m2).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method