NCT00355251

Brief Summary

To determine the influence of atorvastatin on plasma viral replication when the latter is given before and during highly active anti-retroviral therapy (HAART) in patients with HIV infection and viral suppression.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 20, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

July 19, 2006

Last Update Submit

March 19, 2014

Conditions

HIV Infections

Keywords

AtorvastatinViral replicationHIV-1plasma cholesterolCell membrane cholesterol

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is viral load (HIV RNA) in plasma.

    at 12 and 24 weeks

Secondary Outcomes (6)

  • CD4 and CD8, absolute value, percentage and activation.

    during the 32 weeks of follow-up

  • Total cholesterol, HDL and LDL in serum.

    during the 32 weeks of follow-up

  • Cholesterol in cell membrane.

    during the 32 weeks of follow-up

  • Symptoms reported by the patient following the interruption of the HAART therapy or signs detected by the clinician (classification according to the WHO), mainly those which may indicate acute antiretroviral symptoms.

    during the 32 weeks of follow-up

  • Creatinine, urea, creatine kinase (CK), hepatic tests, (AST, ALT, GGT)

    during the 32 weeks of follow-up

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

4 semanas manteniendo el tratamiento antirretroviral e iniciar atorvastatina 40 mg/día. A la semana 4 interrupción HAART y aumentar a 80 mg/día de atorvastatina hasta la semana 32 de seguimiento

Drug: Atorvastatin 40 mg/Atorvastatin 80 mg

B

NO INTERVENTION

4 semanas manteniendo el tratamiento antirretroviral. A la semana 4 interrupción HAART hasta la semana 32 de seguimiento

Interventions

Atorvastatin 40 mg/Atorvastatin 80 mgDRUG

Atorvastatin 40 mg/80 mg

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years.
  • Patients with chronic infection by HIV-1 in stable highly active antiretroviral treatment (\>= 6 months).
  • Undetectable plasma viral load (\<50 copies/mL) in the last 3 determinations over the last 6 months.
  • CD4 \> 500 cells/mm\>=3 in the last two determinations.
  • Documented prior viral load at some time of \>15,000 copies/mL.
  • Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
  • Signature of the informed consent

You may not qualify if:

  • CD4 nadir \<= 200 cells/mm3.
  • Background of infections or other AIDS-defining pathology.
  • Intercurrent infections in the last 6 months.
  • Creatine kinase (CK) \>= 500 U/L.
  • AST or ALT \>= 3 times higher than the upper limit of normality.
  • Treatment with others statins, fibrates, macrolides or fluconazole in the last 3 months.
  • Pregnancy or breastfeeding
  • Patients participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Bonaventura Clotet, MD,PhD

    LLuita contra la Sida Foundation-HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 21, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2006

Study Completion

February 1, 2007

Last Updated

March 20, 2014

Record last verified: 2014-02

Locations

ES(1)