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Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

NCT ID: NCT00845013

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2021-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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HIV Infection Pulmonary Hypertension Endothelial Function HIV Infections

Keywords

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HIV infection pulmonary hypertension endothelial function antiretroviral medication Treatment Experienced

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV Infection

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Priscilla Hsue, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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HIVPAP

Identifier Type: -

Identifier Source: org_study_id