Health Condition 1: null- HIV associated lipodystrophy. Health Condition 2: E881- Lipodystrophy, not elsewhere classified
Conditions
Interventions
Intervention1: Saroglitazar 4 mg: Form:Tablet
Route:-Oral
Frequency :-Once a day
Duration:-52 weeks
Control Intervention1: Placebo: Form:Tablet
Route:-Oral
Frequency :-Once a day
Duration:-52 wee
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 least 18 months. On stable ART regimen for at least 8 weeks prior to inclusion in the study and ART regimen not expected to change during the study. Subjects with waist circumference >90cm for men and >80cm for women and waist to hip ratio of >0.9 in men and >0.8 in women will be included [3]. 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 ââ?¬â?? 500 mg% CD4 cell counts >100 cells/mm3 Viral load Subject has given informed consent for participation in this trial
Exclusion criteria
Exclusion criteria: Subjects on insulin, or other insulin sensitizer therapy (Thiazolidinediones like Pioglitazone) Subjects with Type I Diabetes. Subjects on lipid lowering drugs (e.g. Fibrates, Statins and Resins) in the previous 3 months. HBA1C 9 % Pregnancy and lactation Positive pregnancy test. Women on Oral Contraceptives or Hormone replacement therapy. 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. Previous diagnosis of cirrhosis. Previous or current history of bladder disease and/or hematuria. Patients positive for Hepatitis C antigen. Renal dysfunction (serum creatinine 2 mg %) Subjects with history of gall stone. Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV). New or worsening symptoms of coronary heart disease within the past three months or has any of the following within the past 6 months: ACS, worsening CHF, coronary artery intervention, stroke or Transient Ischemic Attack Subjects with history of myopathies or evidence of active muscle diseases 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 Any other condition that in the opinion of the investigator places the patient at risk by enrolling in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction of Visceral Adipose Tissue (VAT) from baselineTimepoint: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in Triglycerides. Waist circumference. SAT/VAT (Subcutaneous adipose tissue/Visceral adipose Tissue) ratio with CT scan at the level of Lumbar spine 4 (L4) (Appendix 1) HDL Cholesterol LDL Cholesterol VLDL Cholesterol Total Cholesterol Non HDL CholesterolTimepoint: Week 32 and week 52. | — |
Countries
India
Contacts
Public ContactDr Manjunath K
Cadila Healthcare Limited
Outcome results
None listed