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Effects of Pravastatin, Phytosterols and Combination Therapy on Lipid Profile in HIV-infected Patients : An Open-labelled, Randomized Cross-over Study.

Effects of Pravastatin, Phytosterols and Combination Therapy on Lipid Profile in HIV-infected Patients : An Open-labelled, Randomized Cross-over Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20150126002
Enrollment
Unknown
Registered
2015-01-26
Start date
2012-11-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypercholesterolemia HIV Pravastatin Phytosterols Human immunodeficiency virus Lipid

Interventions

Pravastatin 40 mg/day and 2 g/day of phytosterols enriched cereal beverage for 4 weeks,Pravastatin 40 mg/day for 4 weeks,2 g/day of phytosterols enriched cereal beverage for 4 weeks
Experimental Drug,Active Comparator Drug,Active Comparator Dietary Supplement
combination group,pravastatin monotherapy,phytosterol monotherapy

Sponsors

Faculty of Medicine, Prince of Songkla University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) HIV patients aged 20 years or older whose LDL cholesterol was 130 mg/dL or higher at least 2 times in 3 months apart 2) the ARVs had not changed within the previous 6-months period

Exclusion criteria

Exclusion criteria: 1) had an active opportunistic infection 2) were taking any lipid lowering agents during 2-month period before enrollment 3) had hypersensitivity to any statins 4) had transaminase enzyme 3 times higher than the upper limit of normal

Design outcomes

Primary

MeasureTime frame
percent LDL-c reduction of combination therapy to monotherapy 4 weeks after each intervention phase enzymatic in vitro assay for direct quantitative using MODULAR P800 analyzer

Secondary

MeasureTime frame
percent changes of TC, TG, HDL-c and LDL-c after the first phase at 4 week after the first intervention phase enzymatic in vitro assay for direct quantitative using MODULAR P800 analyzer

Countries

Thailand

Contacts

Public ContactNoppadol Kietsiriroje

faculty of medicine, Prince of Songkla University

korn-4425044@hotmail.com6674451463

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026