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Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT00845013
Recruitment Status : Active, not recruiting
First Posted : February 16, 2009
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
HIV Infection Pulmonary Hypertension Endothelial Function HIV Infections

Study Design
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
Study Start Date : November 2007
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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Groups and Cohorts
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Group/Cohort
HIV Infection
HIV-infected individuals with the clinical diagnosis of pulmonary hypertension or HIV-infected individuals who have mildly elevated pulmonary arterial pressures


Outcome Measures
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Primary Outcome Measures :
  1. pulmonary artery pressure [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
serum, plasma, PBMCS, BAL

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00845013     History of Changes
Other Study ID Numbers: HIVPAP
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hypertension
HIV Infections
Acquired Immunodeficiency Syndrome
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
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
Lung Diseases
Respiratory Tract Diseases