CompletedPhase 3Phase 4ACTRN12608000307303

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

Sponsor

St Vincent's Hospital , Sydney

Enrollment

40 participants

Start Date

Feb 1, 2007

Study Type

Interventional

Conditions

lipoatrophy HIV

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial compares three treatments to help reverse fat loss caused by HIV medications. It is for HIV-positive adults aged 18 and older whose virus is well controlled. Participants will be randomly assigned to one of the treatment groups and monitored for changes in body fat over time.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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