A randomised, controlled comparison of uridine, pravastatin or uridine plus pravastatin to accelerate recovery of lipoatrophy in Human immunodeficiency virus (HIV)-infected adults

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000307303

Acronym

URISTAT study

Enrollment

Registered

2008-06-30

Start date

2007-02-01

Completion date

2008-11-28

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Prospective, randomised, 28-week trial in 40 patients. The first step: forty (40) eligible, consented participants will switch from existing PI or NNRTI and commence ritonavir-boosted lopinavir at week 0 (2 tablets twice-daily). The second step: patients on lopinavir/r will be randomised to initiate study therapy at week 4 (4 weeks after initiation of lopinavir/r) for 24 weeks. Eligible subjects will be randomised equally (10 patients per group) to: 1. uridine (36g tid for 10 days per month) 2. pravastatin (40 mg nocte) 3. uridine (36g tid for 10 days per month) + pravastatin (40 mg nocte) 4. delayed treatment arm (DTA) All patients will be offered the combination of pravastatin and uridine for 24 weeks from week 28.

Interventions

A randomised, controlled comparison of uridine 36g three times a day for the first 10 days of each month , pravastatin 40 mg daily or uridine 36g three times a day for the first 10 days of each month plus pravastatin 40 mg daily to accelerate recovery of lipoatrophy in HIV-infected adults. Both drugs are taken orally for 24 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. subcutaneous lipoatrophy in at least 2 body sites, at least one of which is moderate or severe according to both the patient and the doctor 2. HIV viral load <50 copies /ml plasma for at least 3 months 3. use of stable HARRT not including tNRTI for at least 3 months 4. no grade 3or 4 laboratory values at baseline

Exclusion criteria

1. zidovudine (AZT) or stavudine (d4T) in preceding 12 weeks (12/52) 2. ongoing opportunistic infection , other AIDS -defining illness or other illness that would interfere with participation 3. clinically significant renal or hepatic disease 4.lipid levels necessitating statin treatment 5. anabolic steriods, growth hormone, or supra-physiological corticosteriod doeses. 6. pregnancy or breast feeding 7. allergy to any component of the randomised drugs 8. prior use of uridine

Outcome results