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Effect of rosuvastatin on HIV TB coinfection

A randomised controlled trial to study the role of statins in HIV TB coinfection - EROTIC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008171
Enrollment
50
Registered
2017-03-21
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: null- TB-HIV Co-infection

Interventions

Intervention1: Rosuvastatin 10 mg once a day: One arm of the study will be given rosuvastatin along with ATT and ART Control Intervention1: Placebo - folic acid: The second arm will be administered pl

Sponsors

Department of Internal Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.HIV-TB co-infected patients who are being started on ATT-ART 2. Age > 18 yrs

Exclusion criteria

Exclusion criteria: a) Patients already on statins b) Patients already on ART / ATT c) Patients on other lipid lowering agents d) Patients who have abnormal LFT at baseline e) Patients with clinical evidence of myopathy f) Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
1)Weight gain at 6 months 2)Percentage of patients with more than 10 percent increase in CD4 count from baseline 3)To study the change in Vit D levels at 8 weeks, 6 months and 12 months Timepoint: 1)Weight gain at 6 months 2)Percentage of patients with more than 10 percent increase in CD4 count from baseline at 8 weeks and 6 months 3)To study the change in Vit D levels at 8 weeks, 6 months and 12 months

Secondary

MeasureTime frame
Apart from weight gain and rise in CD4 count; statistical analysis about sputum conversion rates, decrease in viral load, ESR, hsCRP and radiological resolution will be done. An analysis of how rapid there is clinical improvement, sputum conversion, improvement in CD4 count and suppression of inflammatory markers & viral load will also be done.Timepoint: 3,6 and 12 months

Countries

India

Contacts

Public ContactGroup Captain V K Sashindran

Armed Forces Medical College

vksashindran@gmail.com9673113005

Outcome results

None listed

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