CClinicalTrials.gg
CompletedNCT00221754Updated Jun 1, 2026

Pravastatin and Protease Inhibitors in HIV-infected Patients

A Phase 2 interventional study of Pravastatin (drug) and Placebo in HIV Infection and Hypercholesterolemia, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

Read the detailed description

Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels.

Design. randomized double-blind, multicentric.

Intervention. Pravastatin versus placebo for 12 weeks.

Eligibility criteria. Positive for anti-VIH antibodies, stable antiretroviral therapy including at least one PI for >= 3 months, plasma HIV-RNA level of \< 50 copies/mL for >= 3 months before randomization, total cholesterol >= 5.5 mmol/L with LDL-cholesterol >= 3.4 mmol/L on fasting status after three months of standardized dietary advice, written informed consent

Outcomes. HIV RNA at 12 weeks

02

Conditions studied

  • HIV Infection
  • Hypercholesterolemia

Keywords

  • HIV,
  • protease inhibitors
  • pravastatin
  • Treatment Experienced
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 21 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ;
  • Age above 18 years
  • Stable antiretroviral therapy including at least one PI for >= 3 months,
  • Plasma HIV-RNA level of \< 50 copies/mL for >= 3 months before randomization,
  • Total cholesterol > = 5.5 mmol/L with LDL-cholesterol > = 3.4 mmol/L on fasting status after three months of standardized dietary advice,
  • signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Current AIDS event or infectious disease
  • Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
  • Psychiatric conditions
  • Biological elevated muscular enzymes
  • Chronic alcohol consumption
  • Pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Pravastatin

    Drug: Pravastatin (drug)

  • Placebo comparator
    placebo

    Drug: Placebo

Interventions

  • DrugPravastatin (drug)
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. HIV RNA

    Time frame: at 12 weeks

Secondary outcomes

  1. Lipid biological markers

  2. Plasma level of protease inhibitors

  3. CD4 count at 12 weeks

  4. Safety

07

Study locations

1 site
  • Hôpital Saint André, Service de médecine interne et maladies infectieuses
    Bordeaux, 33000, France
08

References and documents

Publications

  • Bonnet F, Aurillac-Lavignolle V, Breilh D, Thiebaut R, Peuchant E, Bernard N, Lacoste D, Dabis F, Beylot J, Chene G, Morlat P; GECSA. Pravastatin in HIV-infected patients treated with protease inhibitors: a placebo-controlled randomized study. HIV Clin Trials. 2007 Jan-Feb;8(1):53-60. doi: 10.1310/hct0801-53. PubMed 17434849 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00221754
Lead sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Mar 2003
Completion
Mar 2004
Last update
Jun 1, 2026

Study contacts

Fabrice BONNET, Dr
principal investigator · University Hospital Bordeaux, France
Geneviève CHENE, Pr
study chair · University Hospital, Bordeaux France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion