NCT00577681

Brief Summary

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease for which there is not yet a cure. Antiretroviral therapy (ART) has proven an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. Previous studies indicate that episodic use of ART is associated with increased risk of cardiovascular disease (CVD). This study will determine mechanisms underlying the increased CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,472

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

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

January 1, 2002

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4 years

First QC Date

December 17, 2007

Last Update Submit

October 30, 2019

Conditions

HIV Infections

Keywords

HIVLipoproteinsInflammatory MarkersCoagulation MarkersTreatment Experienced

Outcome Measures

Primary Outcomes (3)

  • Change in lipoprotein particles size and number

    Measured at baseline, Month 1 follow-up visit, and last follow-up visit

  • Change in inflammatory and coagulation markers

    Measured at baseline, Month 1 follow-up visit, and last follow-up visit

  • Reasons for increased CVD risk among HIV-infected individuals

    Measured at study treatment completion

Study Arms (3)

1

Participants from the SMART study who were randomly assigned to episodic or continuous ART and who have no history of CVD

Drug: Antiretroviral Therapy (ART)

2

Participants from the SMART study who were randomly assigned to episodic or continuous ART and who experienced a major CVD event during the study, analyzed along with 2 matched controls

Drug: Antiretroviral Therapy (ART)

3

Participants from the SMART study who have no previous use of ART or have taken ART but not done so within 6 months prior to study entry; allows for a comparison of immediate ART versus deferred ART

Drug: Antiretroviral Therapy (ART)

Interventions

Antiretroviral Therapy (ART)DRUG

Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.

Also known as: Anti-HIV therapy
123

Eligibility Criteria

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

This study will utilize patient data and specimens already collected from the previous parent study, SMART.

You may qualify if:

  • Participant in the SMART study
  • CD4+ lymphocyte count greater than 350 cells/mm3

You may not qualify if:

  • Presence of life-threatening diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Strategies for Management of Antiretroviral Therapy (SMART) Study Group; El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fatkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006 Nov 30;355(22):2283-96. doi: 10.1056/NEJMoa062360.

    PMID: 17135583RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The plasma specimens will be collected using EDTA plasma tubes. For each specimen, four transport tubes (Sarstedt 2.0 mL Micro Tube), each containing 1 mL of plasma, will be prepared and labeled with preprinted bar coded labels. The preprinted bar coded labels specify the patient identification code (PID), visit and specimen type, and the protocol and vial ID. Specimens will be frozen at negative 70 degrees Celcius and shipped on dry ice to a central repository, Advanced Biomedical Laboratories, Cinnaminson, New Jersey, where they will be scanned and put into storage. Paperwork documenting the specimens will be processed by the SDMC, and electronic files will be sent to the central repository.

MeSH Terms

Conditions

HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

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)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Daniel A. Duprez, MD, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 20, 2007

Study Start

January 1, 2002

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 1, 2019

Record last verified: 2019-10