Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

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).

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Infection; Pulmonary Hypertension; Endothelial Function

• Study Type: Observational
• Enrollment (Actual): 365

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pulmonary artery pressure	3 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Priscilla Hsue, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 13, 2009
• First Posted (Estimate): February 16, 2009

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Treatment Experienced; pulmonary hypertension; HIV infection; endothelial function; antiretroviral medication
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lung Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Hypertension; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Hypertension, Pulmonary
• Other Study ID Numbers: HIVPAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO