Aspirin and Antiretroviral Therapy in HIV Infected Patients

NCT00783614 | Terminated Phase 2 Results

• 1 other identifier: PCC-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of HIV treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among HIV infected persons.

Conditions

HIV Infection

Keywords

HIV; Cardiovascular Disease; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events

  At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication

  6 months

• Blood Markers of Inflammation, Endothelial Injury, and Thrombosis

  changes from baseline to 6 months

Study Arms (4)

1

ACTIVE COMPARATOR

Start antiretroviral therapy (ART) immediately and initiate aspirin 325mg po daily

Drug: Aspirin 325mg; Drug: Antiretroviral therapy (ART)

2

PLACEBO COMPARATOR

Start antiretroviral therapy (ART) immediately and initiate placebo pill daily

Drug: Antiretroviral therapy (ART)

3

ACTIVE COMPARATOR

Defer antiretroviral therapy (ART) for 1 month and immediately initiate aspirin 325mg po daily

Drug: Aspirin 325mg; Drug: Antiretroviral therapy (ART)

4

PLACEBO COMPARATOR

Defer antiretroviral therapy (ART) for 1 month and immediately initiate placebo pill daily

Drug: Antiretroviral therapy (ART)

Interventions

Aspirin 325mg DRUG

Patients randomized to Aspirin 325mg po daily versus placebo pill daily

1; 3

Antiretroviral therapy (ART) DRUG

Patients randomized to start ART immediately or defer use for 1 month

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV-infected (by positive HIV Ab or detectable HIV RNA level)
• No ART for at least previous 3 months
• Ready to start or re-start ART (regimen pre-chosen by patient and provider)

You may not qualify if:

• Age \< 18 years, or \>60 years
• Pregnancy
• Current aspirin use
• Presence of known atherosclerotic CVD determined by:
• Previous myocardial infarction
• Significant coronary atherosclerosis by angiography
• Coronary revascularization procedure (coronary stent or surgical bypass)
• Previous cerebral vascular accident (stroke)
• Ischemic cardiomyopathy
• Carotid stenosis (\>25% narrowing by carotid ultrasound)
• Aortic aneurysm
• Symptomatic peripheral vascular disease (claudication)
• Surgical revascularization procedure of peripheral vessels
• Hospitalization (within prior 2 weeks of study entry)
• Concurrent self-limited bacterial infections (does not include chronic viral infections)

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• Kunisaki KM, Quick H, Baker JV. HIV antiretroviral therapy reduces circulating surfactant protein-D levels. HIV Med. 2011 Oct;12(9):580-1. doi: 10.1111/j.1468-1293.2011.00920.x. No abstract available.

  PMID: 21951596 DERIVED

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases

Interventions

Aspirin; Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Drug Therapy, Combination; Drug Therapy; Therapeutics

Limitations and Caveats

Early termination leading to small number of subjects analyzed. Study recruitment difficulty due to inclusion of ART deferral component.

Results Point of Contact

• Title: Dr. Jason Baker
• Organization: Minneapolis Medical Foundation

baker459@umn.edu

612-873-2705

Study Officials

• Jason V Baker, MD, MS

  University of Minnesota; HCMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2008
• First Posted: November 3, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 21, 2017
• Results First Posted: April 17, 2012

Record last verified: 2017-10

Locations

US (1)