A clinical trial to study the effects of ZYH1 in patients with high triglyceride levels in HIV associated lipodystrophy. .[Prospective Randomised Efficacy and Safety of Saroglitazar (PRESS VII)].

Phase 2

Completed

Conditions: Health Condition 1: null- Hypertriglyceridemia in HIV associated lipodystrophyHealth Condition 2: E781- Pure hyperglyceridemia

Registration Number: CTRI/2010/091/000107

Lead Sponsor: Cadila Healthcare Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Age 18- 65 years

Subjects should have confirmed diagnosis of HIV 1 and on highly active antiretroviral therapy (HAART) for at last 18 months.

On stable ART regimen for at least 8 weeks prior to inclusion in the study and ART regimen not expected to change in next 3 months.

Subjects clinically diagnosed as HIV Lipodystrophy (at least 1 moderate or severe Lipodystrophy feature identified by doctor and patient, except isolated abdominal obesity)

Triglycerides between 200 - 500 mg%

Subject has given informed consent for participation in this trial

Subjects whose CD4 count is > 50/mm3

Exclusion Criteria

Subjects on insulin and/or glitazone / glitazar therapy
Pregnancy and lactation
Subjects with history of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2.5 times of upper limits of normal or Bilirubin more than 2 times UNL
Renal dysfunction (serum creatinine > 2 mg%)
Subjects with history of gall stone.
Subjects with history of Cardiac failure.
Subjects with history of myopathies or evidence of active muscle diseases or CPK ≥10 times UNL
Subject with history of alcohol and/or drug abuse
History of allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
History of active Opportunistic infection in last three months.
History of malignancy or active neoplasm.
Any active hormonal disease and/or hormonal treatment that may affect the outcomes of interest such as clinically overt hypo/hyperthyroidism, hypogonadism, hypercortisolism, or treatment with steroids or growth hormone.
Hemoglobin below 9 g/dl or Total leukocyte count below 1000/mm3 or Platelet count below 50,000/mm3
Participation in any other clinical trial in past 3 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TriglyceridesTimepoint: At 6 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
ow density lipoprotein (LDL), <br/ ><br>Very low density lipoprotein (VLDL) High density lipoprotein (HDL) <br/ ><br>Total cholesterol <br/ ><br>Non HDL Cholesterol (Measured value) Apo(a)& Apo B <br/ ><br>Fasting insulin and C-peptide for HOMA beta and IR.Timepoint: At 6weeks and 12 Weeks.