Health Condition 1: null- Hypertriglyceridemia in HIV associated lipodystrophy Health Condition 2: E781- Pure hyperglyceridemia
Conditions
Interventions
Intervention1: ZYH1: Dose -4mg
Frequency-Once daily
Route-Oral
Control Intervention1: NA: NA
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TriglyceridesTimepoint: At 6 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Low density lipoprotein (LDL), Very low density lipoprotein (VLDL) High density lipoprotein (HDL) Total cholesterol Non HDL Cholesterol (Measured value) Apo(a)& Apo B Fasting insulin and C-peptide for HOMA beta and IR.Timepoint: At 6weeks and 12 Weeks. | — |
Countries
India
Contacts
Public ContactDr R H Jani
Cadila Healthcare Limited
Outcome results
None listed