HIV InfectionPhase 2NCT00221754
Pravastatin and Protease Inhibitors in HIV-infected Patients
A Phase 2 study testing Pravastatin (drug) in people with HIV Infection and Hypercholesterolemia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Hypercholesterolemia
- What is being tested?
- Pravastatin (drug)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2003to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current AIDS event or infectious disease
- Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
- Psychiatric conditions
- Biological elevated muscular enzymes
- Chronic alcohol consumption
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Saint André, Service de médecine interne et maladies infectieuses
Bordeaux, 33000
About this study
Official title: Pravastatin in HIV-infected Patients Treated With Highly Active Antiretroviral Therapy
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
- Conditions
- HIV Infection, Hypercholesterolemia
- Being tested
- Pravastatin (drug), Placebo
- Keywords
- HIV,, protease inhibitors, pravastatin, Treatment Experienced
- Medical subject headings
- HIV Infections, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin (drug)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin | Experimental | Not described Receives: Drug: Pravastatin (drug) |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV RNA
Measured: at 12 weeks
Secondary outcomes (4)
Lipid biological markers
Plasma level of protease inhibitors
CD4 count at 12 weeks
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2003
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Fabrice BONNET, Dr, Principal investigator, University Hospital Bordeaux, FranceGeneviève CHENE, Pr, Study chair, University Hospital, Bordeaux France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221754
- Sponsor's protocol ID
- 9268-02
- Other IDs
- 2001-026
- Status last verified
- Jun 2007
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pravastatin in HIV-infected Patients Treated With Highly Active Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00221754
- Acronym / sponsor ID
- 9268-02
- Conditions
- HIV Infection, Hypercholesterolemia
- Keywords
- HIV,, protease inhibitors, pravastatin, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pravastatin | Experimental | Drug: Pravastatin (drug) |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- Current AIDS event or infectious disease
- Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
- Psychiatric conditions
- Biological elevated muscular enzymes
- Chronic alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin (drug) | Drug | Pravastatin |
| Placebo | Drug | placebo |
Primary outcome
HIV RNA
Time frame: at 12 weeks
4 secondary outcomes
Lipid biological markers
Plasma level of protease inhibitors
CD4 count at 12 weeks
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 17434849Bonnet 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.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice BONNET, Dr principal investigator
University Hospital Bordeaux, France
Geneviève CHENE, Pr study chair
University Hospital, Bordeaux France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pravastatin (drug) in people with HIV Infection and Hypercholesterolemia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV RNA (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.