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Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00845013
First received: February 13, 2009
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We will also investigate endothelial function in HIV-infected patients with pulmonary hypertension (Aim 3).


Condition
HIV Infection
Pulmonary Hypertension
Endothelial Function
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • pulmonary artery pressure [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, plasma, PBMCS, BAL


Estimated Enrollment: 125
Study Start Date: November 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV Infection
HIV-infected individuals with the clinical diagnosis of pulmonary hypertension or HIV-infected individuals who have mildly elevated pulmonary arterial pressures

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV infected individiuals with the clinical diagnosis of pulmonary hypertension or who have mildly elevated pulmonary arterial pressures

Criteria

Inclusion Criteria:

  1. Infection with HIV greater than 6 months in duration
  2. Right heart catheterization showing PASP > 30mm Hg
  3. Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment.
  4. Ability to participate in follow-up for the duration of the study.

Exclusion Criteria:

  1. Known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy.
  2. Any known pulmonary disease that could potentially cause pulmonary hypertension.
  3. A pO2 by pulse oximetry below 90% on room air.
  4. Obstructive sleep apnea.
  5. Known collagen vascular disease.

  6. History of anorexigen use

    • 7. Age less than 18 years old.
    • 8. Other co-morbidities for which the investigators, in conjunction with the primary care provider, believe render the participant with an expected survival of 6 months or less.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845013

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

No publications provided

Responsible Party: Priscilla Hsue, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845013     History of Changes
Other Study ID Numbers: HIVPAP
Study First Received: February 13, 2009
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV infection
pulmonary hypertension
endothelial function
antiretroviral medication
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hypertension
Hypertension, Pulmonary
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 03, 2013