A randomised, controlled comparison of uridine, pravastatin or uridine plus pravastatin to accelerate recovery of lipoatrophy in Human immunodeficiency virus (HIV)-infected adults
St Vincent's Hospital , Sydney
40 participants
Feb 1, 2007
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- 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
- HIV viral load <50 copies /ml plasma for at least 3 months
- use of stable HARRT not including tNRTI for at least 3 months
- no grade 3or 4 laboratory values at baseline
Exclusion Criteria8
- zidovudine (AZT) or stavudine (d4T) in preceding 12 weeks (12/52)
- ongoing opportunistic infection , other AIDS -defining illness or other illness that would interfere with participation
- clinically significant renal or hepatic disease
- lipid levels necessitating statin treatment
- anabolic steriods, growth hormone, or supra-physiological corticosteriod doeses.
- pregnancy or breast feeding
- allergy to any component of the randomised drugs
- prior use of uridine
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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
Locations(1)
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ACTRN12608000307303