NCT00641888

Brief Summary

Cardiovascular risk appears to be linked to some degree with inflammation. HIV medications have been linked with cardiovascular risk. In this study we will be measuring levels of chemicals in the body associated with inflammation before and after starting HIV medications in patients with HIV. We hope to understand what happens to these chemicals once a patient with HIV is started on these medications to understand their role in cardiovascular risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

6.6 years

First QC Date

March 19, 2008

Last Update Submit

July 6, 2017

Conditions

HIV Infections

Keywords

Cardiovascular riskInflammatory biomarkersHuman immunodeficiency virus

Study Arms (2)

1

10 patients starting on non-nucleoside reverse transcriptase inhibitor based regimen. 5 women and 5 men.

2

10 patients starting a protease inhibitor based regimen. 5 women and 5 men.

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to an HIV clinic and an infectious diseases clinic affiliated with a tertiary care hospital

You may qualify if:

  • Patients with a CD4 count between 200-400 planning on initiating antiretrovirals.

You may not qualify if:

  • Pregnancy,
  • Recent discontinuation of an antiretroviral within the past 30 days,
  • Active intravenous drug use,
  • Acute febrile illness with temperature \> 100 F,
  • Diagnosis or symptoms of acute infection within the past 30 days,
  • Opportunistic infection or surgical procedure within the past 60 days,
  • Myocardial infarction within the last 30 days,
  • Renal disease (CKD Stages 3-5), and
  • Unstable liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Archana Maniar, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 24, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

US(1)