Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

NCT00845013 | Completed

• 1 other identifier: HIVPAP
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infection; Endothelial Function; HIV Infections; Pulmonary Hypertension

Keywords

HIV infection; pulmonary hypertension; endothelial function; antiretroviral medication; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• pulmonary artery pressure

  3 years

Study Arms (1)

HIV Infection

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Infection with HIV greater than 6 months in duration
• Right heart catheterization showing PASP \> 30mm Hg
• 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.
• Ability to participate in follow-up for the duration of the study.

You may not qualify if:

• Known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy.
• Any known pulmonary disease that could potentially cause pulmonary hypertension.
• A pO2 by pulse oximetry below 90% on room air.
• Obstructive sleep apnea.
• Known collagen vascular disease.
• History of anorexigen use
• \. Age less than 18 years old.
• \. 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, PBMCS, BAL

MeSH Terms

Conditions

HIV Infections; Hypertension, Pulmonary

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; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Priscilla Hsue, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: November 1, 2007
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)